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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:
1994-11-02 to 1994-1-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified reliable without restriction. The study was conducted according to OECD 402 Guidelines and followed GLP.

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)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
1-dodecene dimer, hydrogenated
IUPAC Name:
1-dodecene dimer, hydrogenated
Details on test material:
- Substance type: 1-dodecene dimer, hydrogenated
- Physical state: clear colourless liquid
- Lot/batch No.: C1527-04-2
- Storage condition of test material: Room temperature

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., Kent, U.K.
- Age at study initiation: 10-14 weeks
- Weight at study initiation: Male: 212-244 grams; Female: 213-227 grams
- Fasting period before study: No
- Housing: Individually during exposure and groups of 5 by sex in polypropylene cages
- Diet (e.g. ad libitum): Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Essex, U.K. ad libitum
- Water (e.g. ad libitum): Mains drinking water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24˚C
- Humidity (%): 50% - 69%
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

IN-LIFE DATES: From: 1994-11-02 To: 1994-1-16

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back and flanks
- % coverage: 37 square centimeters
- Type of wrap if used: piece of surgical gauze measuring 10 cm x 5 cm was placed over the treatment area and secured with surgical tape (MICROPORE) wrapped around each end. The gauze was overarapped with cling film and elastic adhesive bandage (ELASTOPLAST).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, wiped with cotton wool moistened with distilled water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.51 mL/kg
- Constant volume or concentration used: yes
Duration of exposure:
24 hours
Doses:
Single application of 2000 mg/kg bw
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: The animals were observed for deaths or overt signs of toxicity 1, 2.5, and 4 hours after dosing and subsequently once daily for 14 days. The test sites were examined for evidence of dermal irritation approximately 30 minutes after bandage removal and on Days 3, 7, 10 and 14. Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Based on the absence of mortality and lack of adverse treatment-related clinical toxicity in male and female rats
Mortality:
No mortality was observed in either male or female rats throughtout the study period.
Clinical signs:
There were no adverse treament-related signs of clinical toxicity observed in the study. No signs of skin irritation were noted during the study.
Body weight:
Body weights of male and female rats remained unaffected through the study period.
Gross pathology:
Gross necroscopy at termination did not reveal any remarkable findings.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Based on the lack of test material related clinical toxicity and mortality, the acute dermal LD50 for 1 -dodecene dimer, hydrogenated is determined to be >2000 mg/kg body weight.
Executive summary:

In an acute dermal toxicity study (Driscoll, R., 1995; Klimisch score = 1), 2000 mg/kg bw of 1 -dodecene dimer, hydrogenated were applied to the intact skin of Sprague-Dawley rats (5/sex). The test material was applied intact under semi-occlusive wrap for a period of 24 hours and animals observed over a 14 day period for signs of irritation and clinical toxicity.

No mortality was observed in either male or female animals through the study period. There were no adverse treament-related signs of clinical toxicity observed and no signs of skin irritation were noted during the study. Body weights of male and female rats remained unaffected through the study period. Gross necroscopy at termination did not reveal any remarkable findings.

Based on the lack of test material related clinical toxicity and mortality, the acute dermal LD50 for 1 -dodecene dimer, hydrogenated is determined to be >2000 mg/kg body weight.