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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it was conducted according to OECD Guideline 402 and GLPs.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Remarks:
UK
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
This substance is very similar in structure to the substance being registered.

- Name of test material (as cited in study report): C20-24 alkenes, branched and linear
- Substance type: Alkenes, C20-24
- Physical state: Liquid
- Analytical purity: Not reported
- Lot/batch No.: C1829-50A
- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Ltd., Kent, UK
- Age at study initiation: 8 to 12 weeks old
- Weight at study initiation: 206 grams to 225 grams
- Fasting period before study: Not reported
- Housing: Individual
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 22°C
- Humidity (%): 44 to 62%
- Air changes (per hr): 15 per hr
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 11 November 1997 To: 25 November 1997

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 35 cm2
- % coverage: Not reported
- Type of wrap if used: Elastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Liquid paraffin BP
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied (weight with unit): 2000 mg/kg (2.52 mL/kg)
- Concentration (if solution): Undiluted (100%)
- Constant volume or concentration used: Yes
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, gross pathology, irritation
Statistics:
None performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: Based on lack of mortality or any other systemic signs of toxicity
Mortality:
There were no deaths.
Clinical signs:
There were no signs of systemic toxicity noted.
Body weight:
Animals gained weight as expected.
Gross pathology:
There were no abnormalities noted during gross pathology.
Other findings:
None reported

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information 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 LD50 for alkenes C20-24, branched and linear was found to be > 2000 mg/kg bw. Alkenes C20-24, branched and linear, are not classified according to EU classification.
Executive summary:

Justification for Read Across

Several criteria justify the use of the read across approach to fill data gaps for linear alpha olefins using isomerised olefins; alpha, internal, linear and branched – multiple carbon number analogues. Studies indicate that changing the carbon number, the location of the double bond, or adding branching does not measurably alter the effects on mammalian health endpoints. There is a consistent toxicity potency pattern for isomerised olefins with a range of carbon numbers and they are considered to have minimal acute toxicity potential. Genotoxicity studies indicate that these materials are not mutagenic. No adverse systemic toxicity was observed in a 90-day repeated oral dose study in which rats were exposed to alkenes, C20-24. The toxicological profile of multiple carbon number isomerised olefins described above indicates a low hazard potential for human health. There do not appear to be any significant toxicological differences between multiple carbon number isomerised olefins and linear alpha olefins. Therefore, read across between these two categories can be justified.

In an acute dermal toxicity study, groups of young adult Sprague-Dawley rats (5/sex) were dermally exposed to alkenes C20-24, branched and linear, undiluted for 24 hours to 35 cm2body surface at a limit dose of 2000 mg/kg bw. Animals were then observed for 14 days.

 

There were no treatment related clinical signs, necropsy findings or changes in body weight. The dermal LD50 was determined to be > 2000 mg/kg in males and females.

 

This study received a Klimisch score of 1 and is classified as reliable without restriction because it was conducted according to OECD Guideline 402 and GLPs.