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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): OS1200
- Molecular formula (if other than submission substance): C19H39N3O3Si
- Molecular weight (if other than submission substance): 385.62
- Smiles notation (if other than submission substance): CC(C)CC(\C)=N\O[Si](C)(O\N=C(/C)CC(C)C)O\N=C(\C)CC(C)C
- InChl (if other than submission substance): Mixture of all possible stereoisomers
- Structural formula attached as image file (if other than submission substance): see Fig.
Specific details on test material used for the study:
See ilustration.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Olac Ltd., Bicester, Oxon, England
- Weight at study initiation: 203 to 239 g
- Housing: Individually in metal cages with wire mesh floors
- Diet (e.g. ad libitum): Ad libitum (SDS LAD 1)
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30 - 70% RH
- Air changes (per hr): 10 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0700 - 1900 hours) in each 24-hour period

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso-lumbar region (one day prior to treatment, hair was clipped), 10% of the total body surface. The test substance was applied by spreading it evenly over the prepared skin.
- % coverage, type of wrap: The treated area (approximately 50 mm x 50 mm) was then promptly covered with gauze which was held in place with a non-irritative dressing encircled firmly around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm (30- 40°C) water and blotted dry with absorbent paper
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.2 mL/kg bw (2000 mg/kg bw)
Duration of exposure:
24 hours
Doses:
1
No. of animals per sex per dose:
5 rats per sex and dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality and clinical signs: twice daily; body weight: Days 1, 8 and 15.
- Necropsy of survivors performed: Yes. All animals were killed on Day 15 by carbon dioxide asphyxiation and were subjected to a macroscopic examination which consisted of opening the abdominal and thoracic cavities. The macroscopic appearance of all examined tissues was recorded.
- Other examinations performed: clinical signs, body weight, macroscopic examination, other: Local dermal irritation at the treatment site was assessed daily and scored (Draize scoring method)

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
There were no signs of systemic reaction to treatment.
Body weight:
In comparison with historical data from the Department of Industrial Toxicology of HRC, slightly low bodyweight gains were recorded for one male and three females on Day 8. All other rats achieved satisfactory bodyweight gains throughout the study.
Gross pathology:
No macroscopic abnormalities were observed for animals killed on Day 15.
Other findings:
Transient slight erythema only was observed at the treatment sites of two animals following removal of the dressings. This reaction was accompanied in both animals by desquamation (characterised by dryness,sloughing and/or scaling). These reactions had resolved in all instances by Day 6. There was no evidence of other dermal reactions among these or among the remaining rats throughout the observation period.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to CLP criteria.
Conclusions:
The LD50 for OS1200 in rats was determined to be greater than 2000 mg/kg bw.
Executive summary:

An acute dermal toxicity study was performed with the test subtance OS-1200 according to EU Method B.3. A group of ten rats (five males and five females) was given a single dermal application of the test substance, as supplied, at a dose level of 2000 mg/kg bw. All animals were killed and examined macroscopically on Day 15, the end of the observation period. There were no deaths and no signs of systemic reaction to treatment. Transient slight erythema only was observed at the treatment sites of two animals following removal of the dressings. This reaction was accompanied in both animals by desquamation. These reactions had resolved in all instances by Day 6. There was no evidence of other dermal reactions among these or among the remaining rats throughout the observation. period. In comparison with historical data from the Department of Industrial Toxicology of HRC, slightly low bodyweight gains were recorded for one male and three females on Day 8. All other rats achieved satisfactory bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic examination on Day 15. Based on the results the LD50 for OS1200 in rats was determined to be greater than 2000 mg/kg bw.