Reaction mass of 1,3-dioxan-5-ol and 1,3-dioxolan-4-ylmethanol

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP lab following OECD guideline

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CEGAV, Argenvilliers, France.
- Age and weight at study initiation: at the beginning of the study, the animals were 4 to 5 months old and had a mean body weight of 3807 g (range: 3485 g to 4185 g)
- Housing: The animals were individually housed in inox cages (Pajon, 75 cm x 57 cm x 50 cm). The cages were suspended in batteries over trays with absorbant paper and each cage contained a platform and enrichment (dumbbell).
- Diet and water (e.g. ad libitum): All animals had free access to pelleted breeding diet "type 110C", batch Nos. 12044 and 12102, (SAFE,
Augy, France) and to tap water (filtered using a 0.22 μm filter) contained in bottles.
- Acclimation period: the animals were acclimated to the study conditions for a period of at least 5 days before treatment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air.
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: During each exposure time, a dry gauze pad was applied to the opposite flank, in order to check that no alteration of the skin is induced by the semi-occlusive dressing and restraining bandage.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

Animal 1: 3-minute, 1-hour and 4-hour exposure
Animals 2 and 3: 4-hour exposure

Observation period:

till 6 days

Number of animals:

3

Details on study design:

TREATMENT
Preparation of the animals
On the day before treatment, two or four areas of skin (3.5 cm x 5 cm) were closely clipped using electric clippers on the right and left anterior and/or posterior flanks of animals.
Care was taken to avoid damaging the skin.

Study design
Rationale for design selection
The sequential study design was as follows.
The test item was applied for 3 minutes on the skin of a single animal (Y30791):
as no full thickness destruction of skin tissue was observed in the first hour after removal of the pad, the test item was applied on another treatment site for 1 hour.

After the 1-hour application on animal Y30791:
. as no full thickness destruction of skin tissue was observed in the first hour after removal of the pad, the test item was applied on another treatment site for 4 hours.

After the 4-hour application on animal Y30791:
. as mean value from grading at 24, 48 and 72 hours after patch removal was < 2.3 for erythema or for edema, the test item was applied on the skin of two other animals for 4 hours (Y30792 and Y30793).

For each animal, the day of dose application was recorded as day 1 of its observation period.

In animal Y30791, the treatment sites are detailed in the following table:
Left flank Anterior 3-minute exposure: 3-minute exposure
Right flank Anterior 3-minute exposure: 1-hour exposure
Left flank Posterior untreated
Right flank Posterior: 4-hour exposure

In other animals (Y30792 and Y30793), the treatment sites are detailed as:
Left flank Posterior: untreated
Right flank Posterior: 4-hour exposure

Application
The test item was placed on a gauze pad, which was then applied to a skin area of approximately 6 cm2. A dosage-volume of 0.5 mL/flank was used.
During each exposure time, a dry gauze pad was applied to the opposite flank, in order to check that no alteration of the skin is induced by the semi-occlusive dressing and restraining bandage. The untreated flank acted as control.
The gauze pad was held in place by a non-irritating semi-occlusive dressing and a restraining bandage. After required period of contact with the skin, the dressing was removed.
After removal of the dressing applied for 3 minutes, any residual test item was wiped off by means of a dry cotton pad.
No residual test item was observed on removal of the dressing applied for 1 hour and 4 hours.

CLINICAL EXAMINATIONS

Morbidity and mortality
Each animal was checked for mortality or morbidity once a day during the treatment and observation periods.

Clinical signs
Each animal was observed once a day, at approximately the same time, for the recording of clinical signs.

Examination of cutaneous reactions
For each exposure period, cutaneous reactions were evaluated approximately 1 hour, 24, 48 and 72 hours after removal of the dressing. After a 3-minute, 1- and 4-hour exposure, since there was no evidence of irritation after 72 hours in male Y30791, the evaluation of cutaneous reactions was stopped. After a 4-hour exposure, since there were persistent irritation reactions at 72-hour reading in males Y30792 and Y30793, the evaluation of cutaneous reactions was extended up to the complete reversibility (at the latest day 6).

Body weight
The body weight of each animal was recorded on the day of treatment and at the end of the evaluation of cutaneous reactions (for males Y30791 and Y30793) or the next day (i.e. on day 7) for male Y30792.

SCORING SYSTEM:
Dermal irritation was graded in each animal according to the following scoring scale:
Erythema and eschar formation:
. no erythema....................................................................................................................... 0
. very slight erythema (barely perceptible)..................................................................... 1
. well-defined erythema..................................................................................................... 2
. moderate to severe erythema......................................................................................... 3
. severe erythema (beet redness) to slight eschar formation (injuries in depth) .... 4
Edema formation
. no edema............................................................................................................................ 0
. very slight edema (barely perceptible)........................................................................... 1
. slight edema (edges of area well-defined by definite raising) ................................... 2
. moderate edema (raised approximately 1 millimeter) ................................................ 3
. severe edema (raised more than 1 millimeter and extending beyond area
of exposure) ........................................................................................................................ 4
Any other cutaneous lesions were noted.

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

Y30793

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: day 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 1 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 5 days

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

Y30792

Time point:

other: 1h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: day 6

Remarks on result:

other: performed on the posterior right flank of the animal

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: day 6

Remarks on result:

other: performed on the posterior right flank of the animal

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

Y30793

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: day 5

Remarks on result:

other: performed on the posterior right flank of the animal

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

Y30793

Time point:

48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: day 5

Remarks on result:

other: performed on the posterior right flank of the animal

Irritation parameter:

edema score

Basis:

animal: #1, 2 and 3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: notrelevant and no edema was recorded

Remarks on result:

other: performed on the posterior right flank of the animal

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

Y30791

Time point:

other: 3 minutes

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: performed on the anterior left flank of the animal in order to assess the absence of destruction of the skin

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

Y30791

Time point:

other: 1 hour

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: performed on the anterior right flank of the animal in order to assess the absence of destruction of the skin

Irritant / corrosive response data:

please refer to table in "irritation/corrosion" results

Other effects:

None other effects were recorded

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions of this study, the test item, Glycerol formal, was slightly irritant when applied topically to rabbits.
However, the test item is not classified as irritating to skin according to the criteria of CLP Regulation.

Executive summary:

The objective of this study was to evaluate the potential corrosive and irritant properties of the test item, Glycerol formal, following dermal application on rabbits.

 

Methods

The test item, Glycerol formal (batch No. 1206191600R), was first applied for periods of 3 minutes, 1 hour and 4 hours to a single male New Zealand White rabbit.

After the 4-hour application, since the mean value from grading at 24, 48 and 72 hours after patch removal is < 2.3 for erythema or for edema, the test item was applied on the skin of two other animals for 4 hours. A dosage-volume of 0.5 mL/flank was used.

The test item was placed on a gauze pad which was then applied to a skin area of approximately 6 cm2. The gauze pad was held in place by a non-irritation semi-occlusive dressing and a restraining bandage. After required period of contact with the skin, the dressing was removed.

Each animal was observed at least once a day for mortality and clinical signs. For each exposure period, cutaneous reactions were evaluated approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily until the reversibility of cutaneous reactions. The mean values of the scores for erythema and edema were calculated for each animal. Body weight was recorded at the beginning and the end of the observation period or the next day for one male.

On completion of the observation period, the animals were used subsequently for the evaluation of the ocular irritation potential of the same test item.

 

Results

No unscheduled deaths occurred during the study and no clinical signs were noted in any animals. The body weight of the animals was unaffected by the test item treatment.

After a 4-hour exposure, a very slight or well defined erythema (grade 1 or 2) was noted in all animals from day 1 to day 3, 4 or 5.

Mean scores calculated for each animal over 24, 48 and 72 hours were as follows:

.erythema: 0.7, 1.0, 1.3; showing no significant inflammation,

.edema: 0.0, 0.0, 0.0; showing no significant inflammation.

 

Conclusion

Under the experimental conditions of this study, the test item, Glycerol formal, was slightly irritant when applied topically to rabbits.

However, the test item is not classified as irritating to skin

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August-September 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP lab following OECD guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Number: two males. These animals were previously used in CiToxLAB France/Study No. 39308 TAL for the evaluation of the dermal irritation potential of the same test item before being allocated to the present study.
Strain and species: New Zealand White rabbits.
Reason for selection of species: rabbit is a non-rodent species accepted by Regulatory Authorities for this type of study and background data from previous studies are available at CiToxLAB France.
Breeder: CEGAV, Argenvilliers, France
Age/weight: at the beginning of the study, the animals were 5 to 6 months old and had a mean body weight of 4370 g (range: 4275 g to 4465 g) (see § Study plan adherence).
Receipt: on arrival, the animals were given a clinical examination to ensure that they are in good condition.
Acclimation: the animals were acclimated for a period of at least 5 days before treatment of the dermal irritation study (CiToxLAB France/Study No. 39308 TAL).
Selection: before treatment, the eyes of each animal were examined in order to use only animals without any signs of ocular irritation or lesions.
Identification: the animals were individually identified by a plastic ear tag at the breeder's facility. After
allocation to groups, each animal received a unique CiToxLAB France identity number.

Environmental conditions
From arrival at CiToxLAB France, the animals were housed in a barriered non-rodent unit.
The animal room conditions were set as follows:
. temperature : 18 ± 3°C, (see § Study plan adherence),
. relative humidity : 50 ± 20%,
. light/dark cycle : 12h/12h,
. ventilation : approximately 12 cycles/hour of filtered, non-recycled air.
The corresponding instrumentation and equipment are checked and calibrated at regular intervals. The
temperature and relative humidity are recorded continuously and the records checked daily and filed.

Housing
The animals were individually housed in inox cages (Pajon, 75 cm x 57 cm x 50 cm). The cages were suspended in batteries over trays with absorbant paper and each cage contained a platform and enrichment (dumbbell).

Food and water
All animals had free access to pelleted breeding diet "type 110C", batch Nos. 12044 and 12102, (SAFE, Augy, France) and tap water (filtered using a 0.22 μm filter) contained in bottles.

Contaminant analyses
The batches of diet were analyzed by the supplier for composition and contaminant levels. Bacterial and chemical analyses of water are performed regularly by external laboratories. These analyses include the detection of possible contaminants (pesticides and heavy metals). No contaminants that could have interfered with or prejudiced the outcome of the study were found in the diet or drinking water.

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

A dosage-volume of 0.1 mL/animal was used.

Duration of treatment / exposure:

The test item was administered in the conjunctival sac of the left eye after gently pulling the lower lid away
from the eyeball. The lids were then gently held together for about one second in order to prevent loss of
the test item.
The right eye remained untreated and served as control.
A dosage-volume of 0.1 mL/animal was used.
Before 24-hour reading, residual test item was removed by means of a rinsing in animal Y30811. Both eyes
were rinsed with sterile isotonic saline solution (0.9% NaCl), under a volume and velocity of flow which will
not cause injury to the eyes.
The eyes of animal Y30812 were not rinsed before 24-hour reading.

Observation period (in vivo):

The eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the test item.
Since both animals showed persistent ocular reactions at the 72-hour reading, the evaluation of ocular reactions was extended up to the complete reversibility (at the latest day 8).

Number of animals or in vitro replicates:

2

Details on study design:

Rationale for design selection
The sequential study design was as follows:
The test item was administered in the left eye of a single animal (No. Y30811):
. as mean value from grading at 24, 48 and 72 hours after instillation was ≥ 2 for conjunctival edema (chemosis) or for conjunctival redness and/or ≥ 1 for iris lesions or for corneal opacity, the test item was administered in the left eye of a second animal (No. Y30812).

After administration to the second animal:
. as mean value from grading at 24, 48 and 72 hours after instillation was ≥ 2 for conjunctival edema (chemosis) or for conjunctival redness and/or ≥ 1 for iris lesions or for corneal opacity, no other animal was treated.

For each animal, the day of dose application was recorded as day 1 of its observation period.

Ocular reactions were graded in each animal according to the following scoring scale:

A) Conjunctival lesions and discharge
Chemosis (lids and/or nictitating membranes)
. no swelling ............................................................................................................................................ 0
. any swelling above normal ................................................................................................................. 1
. obvious swelling with partial eversion of lids .................................................................................. 2
. swelling with lids about half-closed................................................................................................... 3
. swelling with lids more than half-closed .......................................................................................... 4

Redness (refers to the most severe reading for the palpebral
and bulbar conjunctivae, excluding the cornea and iris)
. blood vessels normal ........................................................................................................................... 0
. some blood vessels hyperemic (injected).......................................................................................... 1
. diffuse, crimson color, individual vessels not easily discernible .................................................. 2
. diffuse, beefy red .................................................................................................................................. 3
B) Iris lesions
. normal ................................................................................................................................................... 0
. markedly deepened rugae, congestion, swelling, moderate circum-corneal
hyperemia or injection; any or a combination of any there findings, but iris still
reacting to light (a sluggish reaction being considered positive) ................................................. 1
. no reaction to light, haemorrhage, gross destruction (any or all of these) ............................... 2

C) Corneal lesions
From the 24-hour scoring, the presence of corneal opacification was examined under a UV lamp after instillation of one or two drops of 0.5% sodium fluorescein solution (a clear fluorescence is visible in the areas of opacification). As findings were noted at 24 hours, a fluoresceine examination was conducted at each subsequent scoring time-point until a negative response was obtained.

Opacity (degree of intensity: area most dense taken for reading)
. no ulceration or opacity......................................................................................................................... 0
. scattered or diffuse areas of opacity (other than slight dulling or normal lustre),
details of iris clearly visible ..................................................................................................................... 1
. easily discernible translucent area, details of iris slightly obscured .............................................. 2
. nacreous areas, no details of iris visible, size of pupil barely discernible...................................... 3
. opaque cornea, iris not discernible through the opacity ................................................................. 4

Area of opacity
. one quarter (or less) but not zero ......................................................................................................... 1
. greater than one quarter, but less than a half...................................................................................... 2
. greater than one half, but less than three quarters............................................................................. 3
. greater than three quarters, up to whole area. .................................................................................... 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

scores of animal Y30811

Time point:

24/48/72 h

Score:

2

Max. score:

4

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

scores of animal Y30811

Time point:

24/48/72 h

Score:

1.7

Max. score:

3

Irritation parameter:

iris score

Basis:

mean

Remarks:

scores of animal Y30811

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Irritation parameter:

cornea opacity score

Remarks:

(opacy intensity)

Basis:

mean

Remarks:

scores of animal Y30811

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Irritation parameter:

cornea opacity score

Remarks:

(opacy area)

Basis:

mean

Remarks:

scores of animal Y30811

Time point:

24/48/72 h

Score:

1

Max. score:

4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

scores of animal Y30812

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

scores of animal Y30812

Time point:

24/48/72 h

Score:

2

Max. score:

3

Irritation parameter:

iris score

Basis:

mean

Remarks:

scores of animal Y30812

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

cornea opacity score

Remarks:

(opacy intensity)

Basis:

mean

Remarks:

scores of animal Y30812

Time point:

24/48/72 h

Score:

1

Max. score:

4

Irritation parameter:

cornea opacity score

Remarks:

(opacy area)

Basis:

mean

Remarks:

scores of animal Y30812

Time point:

24/48/72 h

Score:

1

Max. score:

4

Irritant / corrosive response data:

The results obtained were evaluated in conjunction with the nature and the reversibility of the findings observed, whilst taking into account all the reactions of the treated animals.
The test item was classified according to the criteria laid down in Regulation (EC) No. 1272/2008 (CLP) of the European parliament and of the council of 16 December 2008 on classification, labelling and packaging of substances and mixtures.

No ocular reactions were observed in the right untreated control eye.

In the left treated eye of animal Y30811, marked chemosis of the conjunctiva (grade 3) was noted on days 1 and 2 then moderate or slight chemosis (grade 1 or 2) persisted until day 4. Moderate redness of the conjunctiva (grade 2) was observed from day 1 until day 3, then slight conjunctiva reactions (grade 1)
was noted until day 5. Iris lesions (grade 1) were noted on day 2, only. Slight or moderate corneal opacity (grade 1 or 2) was recorded from day 2 to day 4.

In the left treated eye of animal Y30812, moderate chemosis of the conjunctiva (grade 2) was noted on days 1 and 2 then slight chemosis (grade 1) persisted up to day 5. Slight or moderate redness of the conjunctiva (grade 1 or 2) was observed from day 1 until day 7. Slight corneal opacity (grade 1) was
recorded from day 2 to day 5. In addition, lacrimation was recorded on days 1 and 2.

Mean scores calculated for each animal over 24, 48 and 72 hours were as follows:
. chemosis : 2.0 and 1.3; showing eye irritation in 1/2 animals,
. redness of the conjunctiva: 1.7 and 2.0; showing eye irritation in 1/2 animals,
. iris lesions: 0.3 and 0.0; showing no significant eye irritation,
. corneal opacity: 1.3 and 1.0; showing eye irritation in both animals.

Other effects:

MORTALITY
No unscheduled deaths occurred during the study.

CLINICAL SIGNS
No clinical signs of systemic toxicity were noted in any animals.

BODY WEIGHT
The body weight of the animals was unaffected by the test item treatment.

Interpretation of results:

Category II

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions of this study, the test item, Glycerol formal, was irritant when administered by ocular route to rabbits.
According to the criteria of CLP Regulation, the test item should be classified category 2 and assigned the signal word "warning" and the hazard statement "H319: causes serious eye irritation".

Executive summary:

SUMMARY

The objective of this study was to evaluate the potential irritant properties of the test item for the eye, Glycerol formal, following a single administration to rabbits.

Methods

The test item, Glycerol formal (batch No. 1206191600R), was first administered to a single male New Zealand White rabbit.

As mean value from grading at 24, 48 and 72 hours after instillation was ≥ 2 for conjunctival edema (chemosis) and/or ≥ 1 for corneal opacity, the test item was administered in the left eye of a second animal.

After administration to the second animal, as mean value from grading at 24, 48 and 72 hours after instillation was ≥ 2 for conjunctival redness and/or ≥ 1 for corneal opacity, no other animal was treated. The test item was administered in the conjunctival sac of the left eye. The right eye remained untreated and served as control. A dosage-volume of 0.1 mL/animal was used.

Before 24-hour reading, both eyes of animal Y30811 were rinsed with a sterile isotonic saline solution (0.9% NaCl).

Each animal was observed at least once a day for mortality and clinical signs. Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration and then daily until the reversibility of the ocular reactions. The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal. Body weight was recorded on the day of treatment and the end of the observation period. On completion of the observation period, the animals were sacrificed then discarded without macroscopic post-mortem examination.

Results

No unscheduled deaths occurred during the study and no clinical signs of systemic toxicity were noted in any animals.

The body weight of the animals was unaffected by the test item treatment.

In the left treated eye of both animals, slight to marked chemosis and slight to moderate redness of the conjunctiva were noted from day 1 until day 4, 5 or 7. Iris lesions were noted in one of them on day 2, only. Slight or moderate corneal opacity was recorded in both animals from day 2 to day 4 or 5. In addition, lacrimation was recorded in 1/2 animals on days 1 and 2.

Mean scores calculated for each animal over 24, 48 and 72 hours were as follows:

. chemosis : 2.0 and 1.3; showing eye irritation in 1/2 animals,

. redness of the conjunctiva: 1.7 and 2.0; showing eye irritation in 1/2 animals,

. iris lesions: 0.3 and 0.0; showing no significant eye irritation,

. corneal opacity: 1.3 and 1.0; showing eye irritation in both animals.

Conclusion

Under the experimental conditions of this study, the test item, Glycerol formal, was irritant when administered by ocular route to rabbits. According to the criteria of CLP Regulation, the test item should be classified category 2 and assigned the signal word "warning" and the hazard statement "H319: causes serious eye irritation".

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

Sanderson (1959) tested skin irritancy of glycerol formal by placing 1000 mg/kg of test material on clipped skin of rat back and observed no evidence of local irritation at the application site after a 24 -hour exposure period. Cheav et al. (1986) have recorded well-defined skin irritation and necrosis after injection under the mice skin of 0.2 ml of undiluted glycerol formal. Lashmar et al. (1989) have concluded a severe skin irritation using 0.3 ml of 10%-diluted GF.

No details on test material and applied method were available for these 3 disregarded studies. At more raw data were not detailed. As the obtained results were divergent, an OECD 404 and GLP test was performed: Duclos (2012) have demonstrated the slight irritancy of glycerol formal.

Eye irritation

Sanderson (1959) tested ocular irritancy of glycerol formal by placing a 10 µl. standard drop on the corneal surface of one eye of a guinea pig and comparing with the untreated eye. Administration of a single drop (10 µl) to the eye of a guinea pig caused only slight temporary irritation without pupillary constriction or obscuration. At more, an OECD 405 (GLP) test showed that GF was irritant to rabbit eye.

Justification for selection of skin irritation / corrosion endpoint:

This study was selected as the most reliable one.

Justification for selection of eye irritation endpoint:

This study was selected as the most reliable one.

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Skin irritation:

Under the experimental conditions of the study performed by Duclos (2012) according to OECD TG 404 and GLP, the test item, Glycerol formal, was slightly irritant when applied topically to rabbits. However, the test item is not classified as irritating to skin according to the criteria of CLP Regulation.

Eye irritation

Under the experimental conditions of the study performed by Duclos (2012b) according to OECD TG 405 and GLP, the test item, Glycerol formal, was irritant when applied to rabbits eye. The test item is classified as irritating to eye category 2 according to the criteria of CLP Regulation.