Tetrahydrofurfuryl acrylate

Endpoint summary

Description of key information

The irritating potential of Tetrahydrofurfuryl acrylate has been evaluated in rabbits. The substance is considered to be corrosive on skin after an exposure of 4 hours, and corrosive on the eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

August 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf, Switzerland
- Age at study initiation: 18-19 weeks
- Weight at study initiation: 2.9-3.2 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 55+/-10
- Air changes (per hr): 10/15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hr

Observation period:

1h, 24h, 48h and 72h after removal of the dressing.

Number of animals:

3 (2 males, 1 female)

Details on study design:

Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 cm² (10 cm x 10 cm).
On test day 1, 0.5 ml of the test article was applied to the intact skin of the shaved area. It was covered with a 3 cm x 3 cm patch of surgical gauze. The gauze was covered with aluminium foil and the covered with an occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.
Four hours after the application, the dressing was removed and the skin was flushed with luke warm tap water.

OBSERVATIONS :
-viability : daily
-Body weight : pre-test, day 1 and at the termination of test
-Skin reaction: 1h, 24h, 48h and 72h after removal of the dressing.


The study was terminated at the end of observation period (72 hours after application).
No necropsies were performed.

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: individual score : 4-4-4

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

3.2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Individual scores: 4-4-1.67

Irritant / corrosive response data:

The test substance showed a primary irritation score of 7.4 when applied to intact rabbit skin.
Destruction of the treated skin were observed in any rabbit at each measuring interval.

First animal (n°147, male): After 1h, 24h, 48h and 72h, blackish skin (deep necrosis) and edema severe (larger than application area).
Second animal (n°148, male): After 1h, 24h, 48h and 72h, black skin (deep necrosis) and edema severe (larger than application area).
Third animal (n°149, female): After 1h, black skin (deep necrosis) and edema severe (larger than application area). After 24h and 48h: black skin (deep necrosis) and well defined oedema. At 72h: partly black skin (deep necrosis) and slight oedema

Other effects:

The body weight gain of all rabbits was similar.
No acute toxic symptoms were observed in the animals during the tes period, and no mortality occurred.

Interpretation of results:

Category 1C (corrosive) based on GHS criteria

Conclusions:

According to this study, the test substance is considered to be corrosive after 4 hours of exposure.

Executive summary:

The purpose of this primary skin irritation study was to assess possible irritation potential when single doses of Tetrahydrofurfuryl acrylate are place on the skin of rabbits.

Three rabbits were exposed to test substance during 4 hours on intact skin with occlusive patch. Blackish necrosis was observed in all three animals 1hr after removal skin patch. The animals were sacrified after 72 hours of observation. The mean erythema score is 4 out of 4 (24 -48 -72h). And the mean edema score is 3.2 out of 4 (24 -48 -72h).

According to these results, the test substance is considered to be corrosive after 4 hours of exposure.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Boyertown, PA
- Age at study initiation: 4/5 weeks
- Weight at study initiation: 2.2-2.4 kg
- Housing: 1/cage
- Diet (e.g. ad libitum): Fresh purina rabbit chow, provided daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no details but temperature controlled
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml by site

Duration of treatment / exposure:

3 minutes, 1 hour or 4 hours

Observation period:

-3 minute and 1 hour of exposure: observation at 60 minute after patch removal
-4 hour of exposure: observation at 60 minute after patch removal, then 24, 48, 72 hours, day 7 and day 14.

Number of animals:

3 (one male and two females)

Details on study design:

Initially, one rabbit was dosed on sites #1, 2 and 3 with 0.5 ml of the test article. the test article was placed under a 2.5x2.5 cm, 4 ply, surgical gauze patch. Gentle pressure was applied to the gauze to aid in the distribution of the tes substance over the prepared site. Each patch was secured with non-irritating tape. The torso was wrapped with two pieces of plastic, one covering site #1 only, and one covering sites # 2 and #3. This method allowed partial removal of the wrapping to expose site #1 at 3 minutes postdose without disturbing sites #2 and #3. The plastic was applied in a semi-occlusive manner and secured with non-irritating tape. This method of wrapping aids in retaining the test patch in position and retards evaporation of volatile substances.
The wrapping and test article patch covering site #1 was removed at 3 minutes postdose and the site was gently washed with distilled water. A window was cut in the wrapping over site #2 at 1 hour after dosing. The patch was removed and the site gently washed with distilled water. At 4 hours post dose, the torso wrappings and patch covering site #3 were removed and the site gently washed with distilled water.
Since no evidence of a corrosive or severely irritating effect was observed in the initial animal, additional animals were added to the study. Both animals were dosed with 0.5 ml of the test article at site #3. After an exposure period of 4 hours, the wrappings and patches were removed and the sites gently washed with distilled water.

The test sites of all animals were scored for dermal irritation at 1 hour after removal of wrappings. Since no evidence of corrosion or severe irritation was noted on sites #1 or#2, no further scoring was required. Site #3 was scored at 24, 48 and 72 hours. Reactions were scored again on days 7 and 14 following patch removal. Erythema and edema were scred according to the numerical Draize technique. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction. Additional signs were described.
The general health of the animals was monitored at each observation time. Body weights of all animals were recorded pre test adn at study termination.

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(3 min exposure)

Time point:

other: 60 minutes

Score:

0

Max. score:

4

Reversibility:

other: n/a

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(3 min exposure)

Time point:

other: 60 minutes

Score:

0

Max. score:

4

Reversibility:

other: n/a

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(1h exposure)

Time point:

other: 60 minutes

Score:

0

Max. score:

4

Reversibility:

other: n/a

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(1 hr exposure)

Time point:

other: 60 minutes

Score:

0

Max. score:

4

Reversibility:

other: n/a

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(4 hr exposure)

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(4hr exposure)

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(4hr exposure)

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Remarks:

brown area observed at 1h and 24h. Moderate and severe eschar observed from 48h to day 7, cleared at day 14. Poor hair regrowth at day 14.

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(4 hr exposure)

Time point:

24/48/72 h

Score:

2.33

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(4 hr exposure)

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Remarks:

poor hair regrowth observed at day 14.

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(4 hr exposure)

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

After 3 minute exposure, erythema and edema were absent at 60 minutes after patch removal. After 1 hour of exposure, erythema was absent and edema was very slight at 60 minutes following patch removal. After 4 hour exposure, the first animal showed a very slight erythema at 60 minutes following patch removal, and well defined erythema from 24 -72 hours and cleared erythema by day 7. Edema was moderate at 60 minutes, slight at 24 and 48 hours, very slight at 72 hours and cleared by day 7. In additional animal (4 hour exposure), erythema was very slight to well defined at 60 minutes following patch removal, well defined to severe from 24 hours through day 7 and cleared by day 14. Brown areas were noted in 1 animal at 60 minutes and 24 hours, progressing to moderate eschar by 48 hours, and moderately severe eschar at 72 hours and day 7. By day 14, shiny areas were observed on one animal and poor hair regrowth was noted in both. Edema, severe at 60 minutes following patch removal, was moderate at 24 hours, slight to moderate at 48 hours, slight at 72 hours, very slight on day 7 and cleared by day 14.

Other effects:

Body weight changes were within normal limits and no abnormal physical signs were observed.

Interpretation of results:

Category 1C (corrosive) based on GHS criteria

Conclusions:

In conclusion, the test article is corrosive after a dermal exposure of 4 hours in rabbits.

Executive summary:

The objective of this study was too determine the irritant or corrosive effects if any, of a test article when applied dermally. Since the test article was suspected to be corrosive, one rabbit was dosed dermally with the test article (0.5 ml) to three intact sites for an exposure period of 3 minutes on site #1, one hour on site #2 and 4 hours on site #3. Dermal reaction were scored at 60 minutes after each patch removal on all three sites. Site #3 was scored again at 24, 48 and 72 hours and on days 7 and 14 following the patch removal. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Since the reaction of the initial animal did not produce a corrosive or severe irritating effect, additional animals (females) were added to the study. The animals were doses at site #3 for a 4 hour exposure. Dermal reaction were scored at 1, 24, 48 and 72 hours and on days 7 and 14 following patch removal. Bodyweights for all animals were recorded pretest and termination.

After 3 minute exposure, erythema and edema were absent at 60 minutes after patch removal. After 1 hour of exposure, erythema was absent and edema was very slight at 60 minutes following patch removal. After 4 hour exposure, the first animal showed a very slight erythema at 60 minutes following patch removal, and well defined erythema from 24 -72 hours and cleared erythema by day 7. Edema was moderate at 60 minutes, slight at 24 and 48 hours, very slight at 72 hours and cleared by day 7. In additional animal (4 hour exposure), erythema was very slight to well defined at 60 minutes following patch removal, well defined to severe from 24 hours through day 7 and cleared by day 14. Brown areas were noted in 1 animal at 60 minutes and 24 hours, progressing to moderate eschar by 48 hours, and moderately severe eschar at 72 hours and day 7. By day 14, shiny areas were observed on one animal and poor hair regrowth was noted in both. Edema, severe at 60 minutes following patch removal, was moderate at 24 hours, slight to moderate at 48 hours, slight at 72 hours, very slight on day 7 and cleared by day 14.

Body weight changes were within normal limits and no abnormal physical signs were observed.

In conclusion, the test article is corrosive after a dermal exposure of 4 hours in rabbits.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf, Switzerland
- Age at study initiation: 14-15 weeks
- Weight at study initiation: 2.8-3.1 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 55+/-10
- Air changes (per hr): 10/15
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

single exposure

Observation period (in vivo):

1, 24, 48 and 72 hours after administration

Number of animals or in vitro replicates:

2 females and 1 male

Details on study design:

A single dose was administered to the left eye of each animal. The right eye remained untreated and was used as the reference control. The application volume was 0.1 ml per animal.
For observation, the eye were not rinsed.

OBSERVATIONS :
-viability : daily
-Body weight : pre-test, day 1 and at the termination of test
-Eye reaction: 1h, 24h, 48h and 72h after administration

The study was terminated 72 hours after administration of the test article.
All rabbits were killed at the end of the observation period.
No macroscopic organ examination was performed.

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Individual scores : 2-2-2

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

0.8

Max. score:

2

Reversibility:

not reversible

Remarks on result:

other: Individual scores: 1.0-0.7-0.7

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Remarks on result:

other: Individual scores: 3-3-3

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 rabbits

Time point:

24/48/72 h

Score:

2.8

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Individual scores : 2.7 - 3.0 -2.7

Irritant / corrosive response data:

The test article showed a primary irritation score of 8.1 when applied to the rabbit eye mucosa.
In the area of application, no discoloration of the cornea and conjunctivae which could be related to effects of the test article was observed.
Opaqueness of the cornea was observed in any animal during the observation period.

Other effects:

No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.
The body weight fain of all rabbits was similar.

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Based on these results, Tetrahydrofurfuryl acrylate is considered to be severely irritating to the eyes of rabbit.

Executive summary:

The purpose of this primary eye irritation study was to assess possible irritation potential when single doses of Tetrahydrofurfuryl acrylate are placed in the conjunctival sac of rabbit eyes.

Under the conditions of this experiment, Tetrahydrofurfuryl acrylate was found to cause a primary irritation score of 8.1 when applied to the rabbit eye mucosa.

The eye effects are not reversible. In the area of application, no discoloration of the cornea and conjunctivae was observed which could be related to effects of the test article. Opaqueness of the cornea was observed in any animal during the observation period.

Based on these results, Tetrahydrofurfuryl acrylate is considered to be severely irritating to the eyes of rabbit.

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

June/July 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Deviations:

yes

Remarks:

7 day of observation only (instead of 21 days)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Boyertown, PA
- Age at study initiation: no data
- Weight at study initiation: 2.4-2.7 kg
- Housing: 1/cage
- Diet (e.g. ad libitum): Fresh purina rabbit chow, provided daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no details but temperature controlled
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 ml / eye

Duration of treatment / exposure:

one time

Observation period (in vivo):

1, 24, 48, 72 hours, and day 7 post dose.

Number of animals or in vitro replicates:

3 animals (2 females, 1 male)

Details on study design:

One eye of each rabbit was dosed. The contralateral eye served as a control. The test article (0.1 ml) was placed by syringe into the conjectival sac which was formed by gently pulling the lower eyelid away from the eye. After instillation, the lids were held together for approximately one second to insure qdequate distribution of the test article.
The treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours post dose. The eye s were scored again on day 7. All eyes were examined using flashlight equipped with a high intensity bulb. Ocular reactions were graded according to the numerical Draize technique. additional signs were described. Body weights were recorded pretest. The general health of the animals was monitored at each observation time.

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

(3 rabbits)

Time point:

24/48/72 h

Score:

2.1

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Individual scores : 2 - 2 - 2.3

Irritation parameter:

iris score

Basis:

mean

Remarks:

(3 rabbits)

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Individual scores : 1 - 1 - 1

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

(3 rabbits)

Time point:

24/48/72 h

Score:

2.5

Max. score:

3

Reversibility:

not fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Individual scores : 2.3-2.7-2.7

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(3 rabbits)

Time point:

24/48/72 h

Score:

3.7

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Individual scores : 3.7-4-3.3

Irritant / corrosive response data:

Corneal opacity, noted in 3/3 eyes, persisted to day 7 in one eye. Iritis, noted in 3/3 eyes, cleared by day 7. Conjuntival irritation, noted in 3/3 eyes persisted to day 7.

Other effects:

Instances of diarrhea, soiling of the anogenital area and yellow nasal discharge were noted in one animal on day 7. The were no abnormal physical signs noted in two animals.

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Based on these results, the test article is considered to be an ocular irritant in rabbits.

Executive summary:

The objective of this study is to determine the irritant and/or corrosive effects, if any, of a test article when instilled into eye rabbit.

Three healthy rabbits were dosed with test article (0.1 ml) placed into the conjunctival sac of one eye of each rabbit. The eyes were examined and scored by the Draize technique at 1, 24, 48 and 72 hours post dose. The eyes were scored again on day 7. The primary eye irritation score for each rabbit, each day, was calculated. the mean total scores for each time period were also calculated. Body weights were recorded pretest.

Corneal opacity, noted in 3/3 eyes, persisted to day 7 in one eye. Iritis, noted in 3/3 eyes, cleared by day 7. Conjuntival irritation, noted in 3/3 eyes persisted to day 7. Instances of diarrhea, soiling of the anogenotal area and yellow nasal discharge were noted in one animal on day 7. The were no abnormal physical signs noted in two animals.

Based on these results, the test article is considered to be an ocular irritant in rabbits.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion :

In the key study (1999), the objective was to determine the irritant or corrosive effects if any, of a test article when applied dermally. Since the test article was suspected to be corrosive, one rabbit was dosed dermally with the test article (0.5 ml) to three intact sites for an exposure period of 3 minutes on site #1, one hour on site #2 and 4 hours on site #3. Dermal reaction were scored at 60 minutes after each patch removal on all three sites. Site #3 was scored again at 24, 48 and 72 hours and on days 7 and 14 following the patch removal. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Since the reaction of the initial animal did not produce a corrosive or severe irritating effect, additional animals (females) were added to the study. The animals were doses at site #3 for a 4 hour exposure. Dermal reaction were scored at 1, 24, 48 and 72 hours and on days 7 and 14 following patch removal. Bodyweights for all animals were recorded pretest and termination.

After 3 minute exposure, erythema and edema were absent at 60 minutes after patch removal. After 1 hour of exposure, erythema was absent and edema was very slight at 60 minutes following patch removal. After 4 hour exposure, the first animal showed a very slight erythema at 60 minutes following patch removal, and well defined erythema from 24 -72 hours and cleared erythema by day 7. Edema was moderate at 60 minutes, slight at 24 and 48 hours, very slight at 72 hours and cleared by day 7. In additional animal (4 hour exposure), erythema was very slight to well defined at 60 minutes following patch removal, well defined to severe from 24 hours through day 7 and cleared by day 14. Brown areas were noted in 1 animal at 60 minutes and 24 hours, progressing to moderate eschar by 48 hours, and moderately severe eschar at 72 hours and day 7. By day 14, shiny areas were observed on one animal and poor hair regrowth was noted in both. Edema, severe at 60 minutes following patch removal, was moderate at 24 hours, slight to moderate at 48 hours, slight at 72 hours, very slight on day 7 and cleared by day 14.

Body weight changes were within normal limits and no abnormal physical signs were observed.

In conclusion, the test article is corrosive after a dermal exposure of 4 hours in rabbits.

In the supporting study (1984), three rabbits were exposed to test substance during 4 hours on intact skin with occlusive patch. Blackish necrosis was observed in all three animals 1hr after removal skin patch. The animals were sacrified after 72 hours of observation. The mean erythema score is 4 out of 4 (24 -48 -72h). And the mean edema score is 3.2 out of 4 (24 -48 -72h).

According to these results, the test substance is corrosive after 4 hours of exposure.

Eye irritation/corrosion :

Based on the key study (1984), Tetrahydrofurfuryl acrylate was found to cause a primary irritation score of 8.1 when applied to the rabbit eye mucosa.

The eye effects are not reversible. In the area of application, no discoloration of the cornea and conjunctivae was observed which could be related to effects of the test article. Opaqueness of the cornea was observed in any animal during the observation period.

Based on these results, Tetrahydrofurfuryl acrylate is considered to be severely irritating to the eyes of rabbit.

In the supporting study ( 1999), three healthy rabbits were dosed with test article (0.1 ml) placed into the conjunctival sac of one eye of each rabbit. The eyes were examined and scored by the Draize technique at 1, 24, 48 and 72 hours post dose. The eyes were scored again on day 7. The primary eye irritation score for each rabbit, each day, was calculated. the mean total scores for each time period were also calculated. Body weights were recorded pretest.

Corneal opacity, noted in 3/3 eyes, persisted to day 7 in one eye. Iritis, noted in 3/3 eyes, cleared by day 7. Conjuntival irritation, noted in 3/3 eyes persisted to day 7. Instances of diarrhea, soiling of the anogenotal area and yellow nasal discharge were noted in one animal on day 7. The were no abnormal physical signs noted in two animals. Based on these results, the test article is considered to be an ocular irritant in rabbits.

Justification for classification or non-classification

Based on the available experimental data, Tetrahydrofurfuryl acrylate should be classified as skin and eye corrosive according to the Regulation EC n°1272/2008 :

Skin Corr.1C (H314) and Eye Dam. 1 (H318).