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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:
1994-10-31 to 1994-11-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because the study closely followed OECD 402 guidelines and was GLP compliant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
other: Limit test
Limit test:
yes

Test material

Constituent 1
Reference substance name:
1-decene 1-dodecene homoploymer
IUPAC Name:
1-decene 1-dodecene homoploymer
Details on test material:
This substance is very similar with regard to health endpoints to the substance being registered.
- Substance type: Poly alpha olefin (1-decene 1-dodecene homopolymer)
- Physical state: Clear colourless liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Age at study initiation: 10 to 14 weeks old
- Weight at study initiation: Males weighed 213 to 239 grams; Females weighed 212 to 235 grams
- Fasting period before study: Not reported
- Housing: Housed individually in screen bottom polypropylene cages during exposure duration and in group of five by sex for the remainder of the study.
- Diet (e.g. ad libitum): Rat & Mouse expanded diet no. 1, ad libitum
- Water (e.g. ad libitum): Mains drinking water; ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23
- Humidity (%): 50 to 69
- Air changes (per hr): 15 changes/hr
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light


Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Back and flank
- % coverage: Not specified
- Type of wrap if used: Gauze overwrapped with cling film and elastic adhesive


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with cotton wool moistened with distilled water
- Time after start of exposure: 24 hrs


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.43 mL/kg
- Constant volume or concentration used: yes


Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 2.5, and 4 hours after dosing and daily once there after until day 14
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, and histopathology
Statistics:
Details on statistical analysis, if performed, is not provided in the study report.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None of treated animals died during the course of the study.
Clinical signs:
other: No clinical signs were noted during the observation period.
Gross pathology:
No abnormalities were noted following necropsy.

Any other information on results incl. tables

No signs of systemic toxicity, skin irritation or abnormalities were noted during the observation periods or necropsy.  The acute dermal median lethal dose (LD50) of 1 -dodecene, polymer with 1 -decene in the Sprague-Dawley rat was reported to be greater than 2000 mg/kg bodyweight.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The LD50 for 1-decene with 1-dodecene homopolymer via the dermal route is > 2000 mg/mL.
Executive summary:

In an acute dermal toxicity study, five male and female Sprague-Dawley rats were clipped free of hair on the back and flanks and 2000 mg/mL of 1 -decene with 1 -dodecene homopolymer was applied to the exposed skin. Following treatment, animals were observed for overt signs of toxicity at 1, 2.5, and 4 hours after dosing and daily there after until study termination on day 14. Individual body weights were recorded prior to test chemical application and on days 7 and 14. In addition, the treated skin sites were scored for dermal irritation approximately 30 minutes after removal of the dressing and at 3, 7, 10 and 14 days. At study termination, all animals were sacrificed and received a full necropsy.

 

None of treated animals died during the course of the study. No signs of systemic toxicity, skin irritation or abnormalities were noted during the observation periods or necropsy. Based on these observations, the acute dermal median lethal dose (LD50) of 1 -decene with 1 -dodecene homopolymer in the Sprague-Dawley rat was reported to be greater than 2000 mg/kg bodyweight.

 

This study received a Klimisch score of 1 and is classified as “reliable without restrictions” because the study closely followed OECD 402 guidelines and was GLP compliant.

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