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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-referenceopen allclose all
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.

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

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

Resultsopen allclose all
Irritation parameter:
other: Draize scoring
Basis:
mean
Time point:
24 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
other: Draize scoring
Basis:
mean
Time point:
48 h
Score:
0
Remarks on result:
no indication of irritation
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.