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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-10-15 to 2008-10-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline stduy reliable without restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
, 1987-02-24
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
signed 2007-10-15
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
700-380-4
EC Number:
700-380-4
Molecular formula:
A: C25H50O2 B: C27H54O2
IUPAC Name:
700-380-4
Details on test material:
- Name of test material (as cited in study report): Sym08/181598
- Synonym: SymMollient S
- Molecular formula: A: C25H50O2; B: C27H54O2
- Molecular weight: A: 382.68 g/mol; B: 410.73 g/mol
- Physical state: Colourless liquid to solid
- Storage condition of test material: Ambient temperature (10 - 30 °C), dark, dry, in original container
No further information on the test material was stated.

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK
- Age at study initiation: Eight to twelve weeks of age
- Weight at study initiation: 20 g - 252 g
- Housing: The animals were housed in suspended solid-floor polypropylene cages furnished with woodflakes. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study.
- Diet (ad libitum): 2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK
- Water (ad libitum): Mains drinking water
- Acclimation period: At least five days
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 °C to 25 °C
- Relative humidity: 30 to 70 %
- Air exchanges: At least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: On the day before treatment the back and flanks of each animal were clipped free of hair. The calculated volume of test material, as received, was applied as evenly as possible to an area of shorn skin (approximately 10 % of the total body surface area) using a graduated syringe.
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The bandage was carefully removed and the treated skin and surrounding hair wipped with cotton wool moistened with distilled water to remove any residual test material.
- Time after start of exposure: After the 24-hour exposure period

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Dose level was 2000 mg/kg. Dose volume was 2.34 ml/kg. The specific gravity (0.857) was determined and used to calculated the appropriate dose volume for the required dose level.
- Constant volume or concentration used: yes
No further information on the dermal exposure was stated.
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males / 5 females
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 30 minutes, 1,2 and 4 hours after dosing and subsecuently once daily for fourteen days. Individual body weights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: Yes
At the end of the study the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
- Other examinations performed: After removal of the dressing and subsequently once daily for fourteen days, the test sites were exmined for evidence of primary irritation and scored according to the Draize scoring system (Draize, J.H. (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p. 31.). Any other skin reactions, if present were also recorded.
No further information on the study design was stated.
Statistics:
An estimate of the acute dermal median lethal dose (LD50) of the test material was made.

Results and discussion

Preliminary study:
No data
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
other: There were no signs of systemic toxicity.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
- Other observations: There were no signs of dermal irritation.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg body weight.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as acute toxic by the dermal route.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic by the dermal route.

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