Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1963
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Very little information provided on the materials and methods of the study. Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils and esters (linseed, soybean,9-octadecanoate propylene glycol ester and 2-ethylhexyl tallate ester ETP). The C14-C22, 2-ethylhexylesters are listed as similar products on the market to ETP based on fatty acids from other naturally occurring fatty acids This group of epoxies are identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil, ELO epoxidised Linseed oil and ETP epoxidised 2ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters, epoxidised is commonly utilised in the preparation of this dossier. Read-across bridges are used for members of the EOD group where appropriate, is justified based on similar toxicity profiles and structural and functional similarities.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1963

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No information provided to determine methods used to assess ocular irritation - the results indicate that only corneal injury was assessed and other parameters normally included in current guidelines (e.g. iris and conjunctival responses) were not assessed.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Epoxidised Soybean Oil

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data supplied

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
No details are provided to determine how rabbit ocular injury was assessed. No methodological information was available.
Duration of treatment / exposure:
No details for duration of exposure
Observation period (in vivo):
No data
Number of animals or in vitro replicates:
No data
Details on study design:
No details supplied in report publication

Results and discussion

In vivo

Results
Irritation parameter:
cornea opacity score
Basis:
other: the basis for the ocular score is not stated in publication
Time point:
other: No details provided
Score:
1
Reversibility:
not specified
Remarks on result:
other: The value for ocular injury cannot be interpreted since no details are provided for its derivation
Irritant / corrosive response data:
Corneal injury score of 1 recorded

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
The indication is that some degree of corneal injury was induced by instillation of soybean oil, epoxidised. However, the 60 comparative materials listed in this report had scores in the range of 0-10 indicating the corneal injury induced by ESBO is slight or minimal.
Executive summary:

Carcinogenic and acute toxicity potential of the test material was assayed.

Irritation

The irritation result given is provided for irritation on an uncovered rabbit belly and was given a score of 2.

Toxicity

A wide range of toxicity and irritation of epoxy monomers is documented in this report. No consistent correlations with structure are evident.

Carcinogenicity

The test was successfully completed. The test material was not considered to be tumorigenic to the mouse skin.

Sebaceous Gland Suppression

The mena number of sebaceous glands per square centimeter of skin of epoxide-dosed mice has been graded against that of the control mice. As the material was applied undiluted, it was compared to a distilled water control group. This substance was tested by both the sebaceous gland (S.G.T.) and the lifetime tests (L.T.T.). The L.T.T. was negative, the tumour and the cancer index were both 0.0. It was given a S.G.T. grade of 0.

The authors of this report have indicated that the S.G.T., based on the data in this report, is merely a crude screen to indicate potential L.T.T. tumorigens, not a test to be used to from definite positive or negative conclusions concerning tumorigenesis.

Sensitisation:

Sensitisation of guinea pigs was determined by a technique consisting of eight intracutaneous injections (three per week on alternate days) of 0.1 mL of the diluted epoxy materials. A three week incubation period was followed by a challenge dose, and examinations for possible sensitisation reactions were made 24 and 48 hours thereafter.

It was concluded that the test material was not sensitising.