Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 Sep - 24 Sep 2003
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted 1987
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
adopted 1998
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

Test animals

Species:
rat
Strain:
Wistar
Remarks:
(HsdCpb:Wu)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan/Winkelmann GmbH, Borchen, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately 9 - 13 weeks
- Weight at study initiation: males: 236 - 252 g, females: 209 - 221 g
- Fasting period before study: no fasting period
- Housing: animals were individually housed
- Diet: Provimi Kliba 3883.0.15 Maus/Ratte Haltung, Kaiseraugst, Switzerland (ad libitum)
- Water: tap water (ad libitum)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 5
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 10 Sep 2003 To: 24 Sep 2003

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: shaven skin on the back, males: 22.5 cm2, females 20.25 cm2
- Type of wrap: the treated skin was covered with a wet gauze-layer of a ,,Cutiplast steril" coated with air-tight "Leukoflex" and secured in place with "Peha-Haft" cohesive stretch tape; additionally, the mobility of the rats was impaired by a ,,Lomir Biomedical Inc." rat jacket, which was connected with a safety pin to the stretch tape

REMOVAL OF TEST SUBSTANCE
- Washing: the treated area was cleaned with soap and water.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (weight with unit): 2000 mg/kg bw
- Constant concentration used: yes
- For solids, paste formed: no

Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The signs of poisoning and mortality rates were determined several times on the day of application and subsequently at least once daily for an observation period of 14 days. Body weights were determined weekly until the end of the study.
- 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.
Remarks on result:
other: No mortality occured and no clinical signs were noted in the course of the study.
Mortality:
No mortality occurred in the course of the study.
Clinical signs:
No clinical signs were noted in the course of the study.
Body weight:
There were no toxicological effects on body weights or on body weight development in males. One female showed a clear decrease in body weight on day 15 (206 g compared to 216 g on day 1), all other females gained body weight during the course of the study.
Gross pathology:
During scheduled necropsy no macroscopic findings were noted.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: not classified, an LD50 > 2000 mg/kg bw was determined