Reaction mass of 2-hydroxyethyl oleate, oleic acid, and 2-hydroxyethyl palmitate

Endpoint summary

Description of key information

In a reliable in vivo skin irritation study New Zealand White rabbits (n=6) were exposed to a structurally similar substance by application of a 40% solution on clipped skin. The primary dermal irritation index was 0.29 and therefore the substance is not expected to be a skin irritant under the conditions of this study.

The potential for a structurally similar substance to cause irritation or corrosivity of a single dose into the eyes of New Zealand White rabbits (3/sex) was investigated in a reliable in vivo study. Apart from the eye irritation noted, there were no signs of gross toxicity, adverse pharmacological effects or abnormal behaviour. No corneal opacity or iritis was observed during the study. Conjunctival irritation was evident in all treated eyes at 24 hours post-instillation. By 72 hours all but 2 animals were free of irritation. The 24 hour Maximum Mean Total Score was 3 and based on this score the substance is considered to be minimally irritating to eyes.

In a reliable study a structurally similar substance was observed to be a mild eye irritant based on an in vivo eye irritation study New Zealand White rabbits, however the effects were not severe enough to warrant GHS classification.

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:

comparable to guideline study with acceptable restrictions

Remarks:

Read-across to K2 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

Principles of method if other than guideline:

The exposure period was for 24 hours as opposed to 4 hours as stated in the TG.

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

other: Olive oil

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 ml of a 40% solution.

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

Six

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

animal: All animals

Time point:

24/48 h

Score:

0.29

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Interpretation of results:

GHS criteria not met

Conclusions:

The primary dermal irritation index was 0.29 following dermal application of the subtance. Therefore, the substance is not expected to be a skin irritant under the conditions of this study.

Executive summary:

In an in vivo skin irritation study New Zealand White rabbits (n=6) were exposed to the substance by application of a 40% solution on clipped skin. The substance was left on the skin for 24 hours. The treated skin was examined at 1 hour, 24- and 48 hours post-exposure. The substance produced slight erythma at 24 hours post-exposure. At 72 hours there was no erythma or oedema. The primary dermal irritation index was 0.29 and therefore the substance is not expected to be a skin irritant under the conditions of this study.

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:

experimental study

Adequacy of study:

key study

Study period:

5 June 1991 - 8 June 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1g

Duration of treatment / exposure:

Following instillation the animals were returned to their respective cages for 24 hours. The eyes were not washed out following instillation.

Observation period (in vivo):

Ocular lesions were evluated 24, 48 and 72 hours post-administration.

Number of animals or in vitro replicates:

3 Males and 3 females.

Irritation parameter:

maximum mean total score (MMTS)

Time point:

24 h

Score:

3

Reversibility:

other: Partially reversible within 72 hours

Remarks on result:

probability of mild irritation

Other effects:

All animals appeared active and healthy. Apart from the eye irritation noted, there were no signs of gross toxicity, adverse pharmacological effects or abnormal behaviour. No corneal opacity or iritis was observed during th study.Conjunctival irritation was evident in all treated eyes at 24 hours post-instillation. By 72 hours all but 2 animals were free of irritation.

Incidence of Irritation

	Corneal Opacity	Iritis	Conjunctival Irritation
24 hours	0/6	0/6	6/6
48 hours	0/6	0/6	4/6
72 hours	0/6	0/6	2/6

Severity of Irritation

	Maximum Mean Irritation Score
24 hours	3 (minimally irritating)
48 hours	1.3 (practically non-irritating)
72 hours	0.7 (practically non-irritating)

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the scoring system used in this study the substance is considered to be minimally irritating to eyes.

Executive summary:

The irritant or corrosive of a single dose of the substance into the eyes of New Zealand White rabbits (3/sex) was investigated in this in vivo study. One eye of each rabbit was instilled with 0.1g of the test substance and irritation was scored at 24, 48 and 72 hours administration. All animals appeared active and healthy. Apart from the eye irritation noted, there were no signs of gross toxicity, adverse pharmacological effects or abnormal behaviour. No corneal opacity or iritis was observed during th study.Conjunctival irritation was evident in all treated eyes at 24 hours post-instillation. By 72 hours all but 2 animals were free of irritation. The 24 hour Maximum Mean Total Score was 3 and based on this score the substance is considered to be minimally irritating to eyes.

Reference 2

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:

comparable to guideline study with acceptable restrictions

Justification for type of information:

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:

not specified

Species:

rabbit

Strain:

New Zealand White

Vehicle:

other: Olive oil

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml of a 40% solution.

Duration of treatment / exposure:

18 hours

Observation period (in vivo):

7 days.

Number of animals or in vitro replicates:

Six

Irritation parameter:

maximum mean total score (MMTS)

Basis:

animal: All animals

Time point:

other: 1 hour

Score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

maximum mean total score (MMTS)

Basis:

animal: All animals

Time point:

24/48/72 h

Score:

ca. 0 - 8.33

Max. score:

8.33

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Interpretation of results:

Category 2B (mildly irritating to eyes) based on GHS criteria

Conclusions:

The substance is expected to be a mild eye irritant based on an in vivo eye irritation study New Zealand White rabbits.

Executive summary:

In an in vivo eye irritation study New Zealand White 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 was washed out and the eyes were examined at 1 hour, 2, 4 and 7 days post exposure. The substance produced slight to mild conjunctival irritation at 24 hours post-administration. At 7 days, no signs of irritation was observed in all animals dosed. The substance is expected to be a mild 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

Based on the findings of a reliable in vivo skin irritation study conducted on a structurally similar substance and a reliable in vivo eye irritation study conducted on the substance, classification of the substance is not justified.