Reaction mass of Fatty acids, C18-unsaturated, dimers and trimers, esterified with 2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctan-1-ol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

other: Study report pertains to multiple endpoints

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Reason / purpose for cross-reference:

other: Study report pertains to multiple endpoints

Reason / purpose for cross-reference:

other: Study report pertains to multiple endpoints

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

not specified

Test type:

fixed dose procedure

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 149-51

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 212-300g

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Doses:

5 g/kg

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1,2,6, and 24 hours after treatment and daily thereafter for a total of 14 days.
- Necropsy of survivors performed: yes

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 other: g/kg

Based on:

test mat.

Mortality:

No mortality observed.

Interpretation of results:

GHS criteria not met

Conclusions:

Oral LD50 > 5 g/kg in rats.

Executive summary:

Albino rats weighing 212 -300 g received a single oral dose of 5g/kg (5/sex/dose) resulted in an LD₅₀ >5 g/kg. The test substance was not toxic orally in rats under the conditions of the study.

Cross-reference 2

Reason / purpose for cross-reference:

other: Study report pertains to multiple endpoints

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Reason / purpose for cross-reference:

other: Study report pertains to multiple endpoints

Reason / purpose for cross-reference:

other: Study report pertains to multiple endpoints

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: 149-51

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

No information available.

Type of coverage:

occlusive

Preparation of test site:

other: 2 test sites per animal, one intact and one abraded.

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

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

Duration of treatment / exposure:

72 hours

Observation period:

24 and 72 hours

Number of animals:

6

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24h and 72h

Score:

0

Remarks on result:

no indication of irritation

Interpretation of results:

GHS criteria not met

Conclusions:

Primary irritation index: 0.00. The test substance was not a primary irritant to rabbits under the conditions of the test.

Executive summary:

Six new Zealand White rabbits received a single dermal application of 0.5 mL of the test substance to two sites, one intact and one abraded. The test sites were occluded for 24 hours and observed for erythema, edema and other effects 24 and 72h after application. The mean scores from the 24 and 72 hour readings were averaged to determine the primary irritation index, which was 0.00. The test substance was not a primary irritant to rabbits under the conditions of the test.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18-UNSATD., trimers, tris(16-Methylheptadecyl) esters

EC Number:

600-407-9

Cas Number:

103213-22-5

IUPAC Name:

Fatty acids, C16-18-UNSATD., trimers, tris(16-Methylheptadecyl) esters

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: 149-51

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

No information available.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

Observations of corneal opacity, iritis, and conjunctivitis were recorded 24, 48, and 72 hours after treatment.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize method of scoring

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Draize scoring

Basis:

mean

Time point:

24 h

Score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

other: Draize scoring

Basis:

mean

Time point:

48 h

Score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

other: Draize scoring

Basis:

mean

Time point:

72 h

Score:

0

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was not an ocular irritant to rabbits under conditions of the test.

Executive summary:

Six New Zealand White rabbits received a single intraocular application of 0.1 mL of the test substance to one eye, with the other eye serving as a control. The eyes remained unwashed for 24 hours. Observations of corneal opacity, iritis, and conjunctivitis were recorded 24, 48, and 72 hours after treatment. No irritation was observed at 24, 48 or 72 hours therefore the test substance was not considered an ocular irritant to rabbits under the conditions of the test.