Glycerides, tallow sesqui-, hydrogenated, propoxylated

Endpoint summary

Description of key information

In a reliable in vivo skin irritation/corrosion study, rabbits were dermally exposed to a formulation of the substance for 4 hours. The substance produced evidence of irritation upon dosing.The mean irritation score was 4 and therefore the formulation is expected to be a moderate skin irritant under the conditions of this study. In a reliable in vivo study a structurally similar substance was non-irritating to the skin of New Zealand White rabbit.

The substance is not expected to be an eye irritant based on a reliable in vivo eye irritation study in which three rabbits were exposed to the substance by instillation of the substance into one eye. In a reliable in vivo study a structurally similar substance was found to be minimally irritating to the eyes of New Zealand White rabbit.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Read-across to K1 study therefore K2 is the maximum Klimisch value.

Justification for type of information:

Read-across approach - see read-across justification in section 13.

Reason / purpose for cross-reference:

read-across source

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml of undiluted test material was applied.

Duration of treatment / exposure:

1 hour and 3 minute exposure periods

Observation period:

1, 24, 48 and 72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Dorsal / flank area
- % coverage: 2.5 X 2.5 cm
- Type of wrap if used: Cotton gauze patch secured with a surgical adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle swabbing with cotton wool soaked in distilled water.


SCORING SYSTEM: Draize Classiification Scheme

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hour

Score:

0

Max. score:

4

Remarks on result:

other: Max. score is 4 for erythema and 4 for edema.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No evidence of skin irritation was noted during the study.

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

The substance produced a primary irritation index of 0.0 and was classified as a non-irritant according to Draize classification scheme.

Executive summary:

An in vivo study was performed to assess the irritancy potential of the substance to the skin of New Zealand White rabbit according to OECD TG 404 (Acute Dermal Irritation/Corrosion). A single 4 -hour, semi-occluded application of the substance to the intact skin of 3 rabbits produced no evidence of skin irritation. Three-minute and 1 -hour semi-occluded applications of the substance to the intact skin of 1 rabbit produced no evidence of skin irritation. The substance produced a primary irritation index of 0.0 and therefore classified as non-irritant to rabbit skin according to the Draize classification scheme.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Read-across to K1 study therefore K2 is the maximum Klimisch value.

Justification for type of information:

Read-across approach - see read-across justification in section 13.

Reason / purpose for cross-reference:

read-across source

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated eye was used as control

Amount / concentration applied:

undiluted
Amount applied: 0.1 ml

Observation period (in vivo):

1, 24, 48 and 72 hour

Number of animals or in vitro replicates:

3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 hr average

Score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 hr average

Score:

0

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 hr average

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 24 hrs

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 hr average

Score:

0

Irritant / corrosive response data:

No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted in all treated eyes at the 24h-observation. Treated eyes appeared normal at the 48-hour and 72-hour observation.

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance produced a maximum group mean score of 10.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The substance did not meet the criteria for classification according to EU labelling.

Executive summary:

The irritancy potential of the substance to the eye of New Zealand White rabbit was assessed according to the OECD TG 405 (Acute Eye Irritation/Corrosion). In the absence of skin irritation data a Rabbit Enucleated Eye Test was performed prior to the in vivo study and the results from this study indicated that the substance qwas unlikely to cause severe ocular irritancy. A single application of the substance to the unwashed eye of three rabbits produced moderate conjunctival irritation. All treated eyes appeared normal at the 48-hour observation. the substance produced a maximum group mean score of 10.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6 October 1986 - 13 October 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

May 12, 1981

Deviations:

not specified

GLP compliance:

not specified

Species:

rabbit

Strain:

other: Kieine white Russians, Chbb-SPF

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 cm3

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

1, 24, 48 and 72 hours and 6 days after application.

Number of animals or in vitro replicates:

Three

Irritation parameter:

overall irritation score

Basis:

animal: all three

Time point:

24/48/72 h

Score:

0.83

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 hr

Score:

3.33

Reversibility:

fully reversible within: 24

Remarks on result:

other: mild irritation upon dosing only

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Interpretation of results:

GHS criteria not met

Conclusions:

The test material was not irritating to the eyes.

Executive summary:

In an in vivo eye irritation study three rabbits were exposed to the substance by instillation of the substance into one eye. The corresponding eye of the same animal was left untreated and acted as concurrent control. The treated eyes were washed out with sodium chloride solution after 72 hours. The eyes were examined at 1, 24, 48 and 72 hours and 6 days post-exposure. The substance produced slight to mild conjunctival irritation upon dosing. At 7 days, no conjunctival irritation was observed in all animals dosed. No corneal involvement or irritis was observed during the 7 day observation period. The substance is not expected to be an eye irritant under the conditions of this study.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The substance was tested as part of a formulation which contained 4% of a corrosive substance. It is likely that the presence of a corrosive substance will have lead to the finding of irritancy and therefore the classification for skin irritancy is based on the findings of a reliable study conducted on an analogue substance. Based on these findings, classification for skin irritation is not justified.

Based on the findings of a reliable in vivo eye irritation study conducted on the substance and also on an analogue substance, classification for eye irritation is not justified.