Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06 - 20 Jan 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted Feb 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
The Department of Health of the Government of the United Kingdom, UK
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
other: Wistar HsdRccHan:WIST
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Bicester, UK
- Age at study initiation: 8 - 12 weeks old
- Weight at study initiation: 230 - 256 g (males); 200 - 219 g (females)
- Fasting period before study: overnight until 3 - 4 hours after dosing
- Housing: during the 24-hour exposure period, animals were individually housed in suspended solid-floor polypropylene cages furnished with woodflakes and with enviromental enrichment items. For the period before and after exposure, animals were housed in groups of 5 by sex.
- Diet: 2014 Teklad Global Rodent diet (Harlan Teklad, Bicester, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: the test substance was moistened with arachis oil BP
Details on dermal exposure:
TEST SITE
- Area of exposure: back and flank of the animal
- % coverage: approximately 10
- Type of wrap if used: a piece of surgical gauze was placed over the treatment area and secured with a semi-occlusive self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, residual test substance was removed using cotton wool moistened with arachis oil
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- For solids, paste formed: no, the test substance was moistened using arachis oil BP
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed for mortality and clinical signs 0.5, 1, 2 and 4 hours after administration, and daily thereafter for the rest of the study period; the body weight was recorded on Day 0 (prior to dosing), 7 and 14; the test site was scored for skin irritation (erythema and edema) daily for the entire observation 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 during the study period.
Clinical signs:
No treatment-related clinical signs were observed during the 14-day observation period.
Body weight:
4/5 males and 2/5 females showed the expected body weight gain during the observation period. 1/5 males showed a body weight loss (< 10%) during week 2 and 3/5 females had no increase in body weight during either week 1 or week 2.
Gross pathology:
The necropsy and gross pathology examination did not reveal any substance-related findings.
Other findings:
- Other observations: No erythema or edema was noted at the test site in any animal during the observation period.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified