Registration Dossier

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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995
Reference Type:
other: amendment
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3043/V9Z

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
-Animal species: rat / wistar / chbb: thom (SPF)
- Animal breeder: Dr. K. Thomae GmbH, Biberach, Germany
- Age of the animals: young adult animals.
- Animal weights at start of the study: animals of comparable weight; (200g - 300g) (+/- 20 % of the mean weight).
- Animal identification: individual identification using cage cards and group identification by tail marking.
- Room temperature/ Relative humidity: fully air-conditioned rooms. 20-24 degrees Celsius and of 30 -70 % for relative humidity.
- Day/night rhythm: 12 h/12 h (6.00 a.m. - 6.00 p.m./ 6.00 p.m. - 6.00 a.m.)
- Type of cage: stainless steel wire mese cages, type DK-III (Becker & co., Castrop-Rauxel, Germany)
- No. of animals per cage: single housing.
- Bedding: no bedding in tee cages; sawdust in the waste trays.
- Drinking water: tap water ad libitum per day.
- Diet: Kliba Labordiaet 343, Klingenthalmuehle AG Kaiseraugst, Switzerland, ad libitum.

Analysis of drinking water:
The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the tecenical services of BASF AG as well as for the presence of germs by a contract laboratory.

Analysis of feed:
The feed used in the study was assayed for chemical and microbiological contaminants.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal an dorsolateral parts of the trunk; about 50 cm2
- Type of wrap if used: the bandage consists of four layers absorbent gauze, Ph. Eur. Lohmann GmbH & Co. Kg and Fixomull stretch (adhesive fleece), Beiersdorf AG)

REMOVAL OF TEST SUBSTANCE
- Washing: rinsed with water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 2000 mg/kg bw
- Concentration: 0.5 g/mL
- Constant volume or concentration used: yes, constant concentration
- For solids, paste formed: yes (suspension)

VEHICLE
- Amount applied: 4 mL/kg
- Stability of test substance in vehicle: substance is stable in tap water for at least 4 days in a concentration of 1 mg/mL
Duration of exposure:
single exposure
Doses:
2000 mg/kg b.w.
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals;
- Frequency of weighing: Individual body weights shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period).
- Necropsy of survivors performed: yes

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:
No mortality occurred.
Clinical signs:
No signs of systemic toxicity could be noticed. Cageside observtions did not reveal any signs of toxicity.
The following local effects were reported:
females: 2 animals depicted well-defined erythema at study day 1 and another 2 animals displayed slight erythema. 2 Animals showed scaling at day 7. All signs were fully reversible at day 8.
males: 4 animals displayed well defined erythema at day 1, 1 animal had slight erythema the same day. All signs were fully reversible within 2 days.
Body weight:
The body weights developed in the normal range:
- mean weight male animals: day 0: 276 g; day 7: 291 g; day 13: 241 g
- mean weight female animals: day 0: 233 g; day 7: 234 g; day 13: 241 g
Gross pathology:
No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met