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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:
1993-09-13 to 1993-11-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restrictions because it closely followed OECD Guideline 402 and is GLP compliant.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
Reason / purpose:
read-across: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sample 1205-48 (Isomerised C16 Olefin)
- Substance type: C16 isomerised olefin
- Physical state: Clear colourless liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, Texas
- Age at study initiation: Young adult 3 to 6 months
- Weight at study initiation: Males (2.425 to 2.875 kilograms); Females (2.400 to 2.750 kilograms)
- Housing: Suspended, wire bottom, stainless steel; one animal per cage
- Diet (e.g. ad libitum): Purina Rabbit Chow; fed in measured amounts
- Water (e.g. ad libitum): Tap water; ad libitum
- Acclimation period: 5 days


Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal surface of the trunk
- % coverage: 10%
- Type of wrap if used: Surgical gauze covered with non-irritating adhesive tape which was further covered with semi-permeable dressing and again wrapped with non-irritating adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with room temperature tap water and a clean wet cloth
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.37 mL/kg equivalent to 2020 mg/kg
- Concentration (if solution): Not applicable
- Constant volume or concentration used: Yes



Duration of exposure:
24 hours
Doses:
2020 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: 0.5, 3, and 6 hours after exposure and daily until day 14
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs and body weight
Statistics:
Statistical analysis, if performed, is not presented in the study report.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 020 other: mg/kg
Mortality:
One male died on day 14 of the study after all study observations were made. The authors reported that this death is not related to treatment.
Clinical signs:
No notable observations were reported.
Body weight:
No changes in body weight were noted; however one male that died on day 14 of the study lost weight during the course of the study.




Gross pathology:
The male rabbit that died on day 14 of the study had mottled lungs with white nodules throughout. However, this observation was considered to be unrelated to treatment. None of the other animals exhibited any abnormalities.

Any other information on results incl. tables

Body weight gain was not affected from exposure to hexadecene. However, one male that died on day 14 of the study lost weight during the study. Toxicological and pharmacological signs were not noted. There were no signs of dermal irritation during the 14 day observation period. Gross necropsy at study termination revealed no observable abnormalities in most animals. However, one male that died on day 14 of the study revealed mottled lungs with white nodules everywhere. None of the other treated animals died during the course of the study. Based on these results, the LD50for hexadecene in albino rabbits is > 2020 mg/kg (2.37 mL/kg).

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Not classified because LD50 is greater than the requirements for a Category 4 toxicant (2000 mg/kg) Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 for hexadecene is greater than 2020 mg/kg.
Executive summary:

In acute dermal toxicity study, five male and female New Zealand White rabbits were clipped free of hair on the dorsal surface of the trunk and treated with 2020 mg/kg (2.37 mL/kg) undiluted hexadecene that was held in contact with the skin for 24 hours. After 24 hours the animals were observed for toxicological and pharmacological effects and mortality at 0.5, 3, and 6 hours after treatment and at least once daily until study termination on day 14. Animals were sacrificed for necropsy on day 14.

Body weight gain was not affected from exposure to hexadecene. However, one male that died on day 14 of the study lost weight during the study. Toxicological and pharmacological signs were not noted. There were no signs of dermal irritation during the 14 day observation period. Gross necropsy at study termination revealed no observable abnormalities in most animals. However, one male that died on day 14 of the study revealed mottled lungs with white nodules everywhere. None of the other treated animals died during the course of the study. Based on these results, the LD50for hexadecene in albino rabbits is > 2020 mg/kg (2.37 mL/kg).

 

This study received a Klimisch score of 1 and is classified as “reliable without restrictions” because it closely followed OECD Guideline 402 and is GLP compliant.  This study will influence the DNEL(s).