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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not stated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted prior to introduction of test guidelines or adoption of GLP, however the testing laboratory is reputable and the study design appears to follow methods similar to those adopted subsequently as international standards. 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.
Justification for type of information:
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:
study report
Title:
Unnamed
Year:
1955
Report Date:
1955

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Similar to OECD Guideline 402 or EC Method 403 but as a rangefinding test fewer rabbits used than recommended in formal guidelines adopted many years after study conduct.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Liquid. Used undiluted. A pint of material was supplied from Run No.4, code 272, R.D. 82 on 19 August 1955.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: 3-5 months old
- Weight at study initiation: mean weight 2.5 kg
- Fasting period before study: No
- Housing: No data
- Diet (e.g. ad libitum): Rockland rabbit ration
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From:No details provided To: No details provided

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap if used: Impervious 'Vinylite' sheeting

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: Exposure period was 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 ml/kg bw applied undiluted
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes
Duration of exposure:
24 hour occluded exposure
Doses:
20 ml/kg bw
No. of animals per sex per dose:
NOt stated, but report wording suggests only four rabbits were treated
Control animals:
not specified
Details on study design:
No further details available
Statistics:
Thompson's method for calculating median lethal doses, used where appropriate

Results and discussion

Preliminary study:
No data
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 20 mL/kg bw
Based on:
test mat.
Mortality:
Four rabbits survived treatment at 20 ml/kg bw. It appears that only four rabbits were treated and therefore there were no mortalities.
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data
Other findings:
Topical application of 20 ml/kg bw to rabbit skin under fully occluded conditions for 24 hours, resulted in no deaths. All four treated rabbits survived 24 h treatment and the 13 day observation period

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
24 hour exposure to undiluted ESBO under fully occluded conditions did not result in signs of reaction to treatment, mortality or evidence of dermal toxicity in the four rabbits tested.
Executive summary:

24 hour exposure to undiluted ESBO under fully occluded conditions did not result in signs of reaction to treatment, mortality or evidence of dermal toxicity in the four rabbits tested.