Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Sep 14 - 28, 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: F. Winkelmann, 33178 Borchen
- Age at study initiation: 9 - 13 weeks
- Weight at study initiation: 219 g (range from 200 to 239 g).
- Fasting period before study: no
- Housing: separately in type III Makrolon cages with a shelter, placed on mobile racks
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 24 °C
- Humidity (%): 42 to 62 %.
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 h

IN-LIFE DATES: From: day 1 To: day 15

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 6 x 6 cm
- % coverage: 100
- Type of wrap if used: self-adhesive fabric (Fixomull stretch, Beiersdorf).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.55 g/kg
- Concentration (if solution): 1285.6 g/L
- Constant volume or concentration used: no

Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 (m) / 5 (f)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
Standard statistical methods have been applied for data processing.

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:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
No signs of toxicity were detected in the rats after treatment with 2000 mg/kg bw.
Body weight:
The body weight development was inconspicuous.
Gross pathology:
The gross pathological examination revealed no alterations.
Other findings:
No signs of toxicity were detected in the rats after treatment with 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material can be considered to have no acute toxic potential and to have a LD50 value higher than 2000 mg/kg bw after dermal application to rats.
Executive summary:

Study design

The test material was tested for acute toxicity in rats after single dermal administration of 2000 mg/kg body weight. The study was performed according to the OECD Guideline for Testing of Chemicals, No. 402, and according to  Commission Directive 92/69EEC.

Results

No signs of toxicity were seen in the rats (5 males, 5 females) after treatment with 2000 mg/kg of the test item.
The body weight development of the rats was inconspicuous during the study.
There were no deaths during the course of the study.
The gross pathological examination revealed no alterations.

Conclusion

The test material can be considered to have no acute toxic potential and to have a LD50 value higher than 2000 mg/kg after dermal application to rats.