Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
9 May to 23 May, 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test method according to EU method B.3. GLP 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))
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): OS-2200 (489-95A).
- Physical state: Clear to light yellow liquid.
- Analytical purity: >92%.
- Lot/batch No.: 38659-14.
- Expiration date of the lot/batch: 1 January 1996.
- Storage condition of test material: Room temperature in dark under nitrogen.

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.
- Age at study initiation: 7-10 weeks.
- Weight at study initiation: 214-238g.
- Housing: individually housed in metal cages with wire mesh floors.
- Diet (e.g. ad libitum): Ad libitum. SDS LAD 1, a standard laboratory rodent diet.
- Water (e.g. ad libitum): Ad libitum.
- Acclimation period: 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature : 22+/- 3 ºC.
- Humidity : 30-70%.
- Air changes : 10 to 15 air changes per hour.
- Photoperiod: 12hrs dark / 12hrs artifical light.

IN-LIFE DATES: From 9 May 1995 to 23 May 1995.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorso-lumbar region (clipped one day prior treatment).
- Treated area: The test substance was applied by spreading it evenly over the prepared skin (50mmx50mm).
- Type of wrap if used: The treated area was covered with gauze which was held in place with a non-irritative dressing encircled firmly around the truck.

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

TEST MATERIAL
- Amount(s) applied: 2.0 g/kg body weight.

Duration of exposure:
24 h.
Doses:
2.0 g/kg bw.
No. of animals per sex per dose:
5/sex/dose.
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: Mortality was checked at least twice daily. Animals were observed for clinical signs soon after dosing and at frequent intervals for the remainder of Day 1 (a period of five hours). On subsequent days animals were observed once in the morning arid again at the end of the experimental day. Local dermal irritation at the treatment site was assessed daily using Draize numerical scoring. Individual body weights were recorded on day 1 (prior to dosing), 8 and 15. All animals were killed on day 15 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.
Statistics:
The LD50 value, and where possible, the value of males and females separately, was calculated from the observed mortality data, using established procedures.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LDLo
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths following a single dermal application of OS-2200 to a group of ten rats at a dosage of 2.0 g/kg bw.
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 body weight gains were recorded for two males and two 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:
Sites of application showed no irritation or other dermal changes.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute lethal dermal dose to rats was found to be greater than 2.0 g/kg bw.
Executive summary:

An acute dermal toxicity study was performed according to EU method B.3 under GLP conditions. A group of ten rats (5 males and 5 females) was dermally exposed to 2.0 g/ kg bw of OS-2200 for 24 hours. Animals were observed for 14 days and there were no deaths, signs of systemic reaction or dermal changes in sites of application. Animals were killed on day 15 and subjected to a macroscopic examination: there were no macroscopic abnormalities. The acute lethal dermal dose to rats was found to be greater than 2.0 g/kg bw.