Registration Dossier

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
Study period:
2002-06-05 to 2002-07-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD test under GLP
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes (incl. certificate)
Test type:
other:
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Weight at study initiation: male: 231 - 255 g, female: 220 - 232 g
- Housing: semi barrier in air-conditioned rooms
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 55 +/- 10 % rel. humidity
- Air changes (per hr): 10/h
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: approx. 10 % of the total body surface


REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by using tap water
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bodyweight




Duration of exposure:
24 h
Doses:
2000 mg/kg bw (Limit test) for each sex
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: a clinical examination was made at least twice a day on the day of dosing and once a day thereafter
- Weighing on day: 0, 7 and 14
- Necropsy of survivors performed: gross necropsy.
Statistics:
not applicable

Results and discussion

Preliminary study:
not apllicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: None
Mortality:
No mortality has been observed.
Clinical signs:
No clinical signs have been observed.
Body weight:
Weight gain in male animals was within the expected range. For females slight reduction was found.
Gross pathology:
No changes were found in any animal.
Other findings:
- Other observations: none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 was determined to be > 2000 mg/kg bw.
Executive summary:

An acute dermal toxicity test according to OECD 402 was performed. The test item was administered topically at a single dose (2000 mg/kg bw) by applying uniformly over an area which was approx. 10% of the total body surface. 5 male animals as well as 5 female animals were used. The test item was held in contact by an occlusive dressing with the skin throughout a 24 -hour period. No mortality occured during the study. No clinical signs of toxicity were observed throughout the observation period. Weight gain in male animals was within the expected range. For females slight reduction was found. No macroscopic findings were observed at necropsy. Therefore, the LD50 (dermal, rat) was determined to be > 2000 mg/kg bw.