Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 May - 15 June 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: JMAFF Acute Dermal Toxicity (2-1-2) Nohsan No. 8147
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Appearance: Clear, colourless liquid
Storage conditions: Room temperature in the dark
Lot number: 52834
Expiry: December 2006
Purity: >98%

Test animals

Species:
rat
Strain:
other: Crl:CD BR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approximately eight to twelve weeks of age
- Weight at study initiation: 221 to 365 g
- Housing: metal cages suspended in mobile stainless steel racks
- Acclimation period:seven days
- Diet: ad libitum
- Water: ad libitum
- Environmental enrichment: small soft white untreated wood blocks during the acclimatisation period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23°C
- Humidity (%): 40 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0600 - 1800 hours GMT) in each 24-hour period

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 10% of the total body surface area
- Type of wrap if used: porous gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water (30 - 40°C)
- Time after start of exposure: end of 24 hours exposure period

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bodyweight
Duration of exposure:
24 h
Doses:
2000 mg/kg bodyweight
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 and weighing: Days 1 (prior to dosing), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: The macroscopic appearance of all tissues was recorded.

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:
Signs of toxicity related to dose levels:
No deaths occurred and no signs of toxicity were observed.
Body weight:
Low bodyweight gains were recorded for two females (Nos. A7 and A8) on Day 8 and for one female (No. A10) on Day 15.
All other animals were considered to have achieved satisfactory bodyweight gains throughout the study.
Gross pathology:
Effects on organs:
No abnormalities were noted in any animal at the macroscopic
examination at study termination on Day 15.
Other findings:
Signs of toxicity (local):
No signs of toxicity or dermal irritation were observed.

Bodyweight gain was reduced in two females on Day 8 and for
one female on Day 15.

Bodyweight was satisfactory in all other animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute lethal dermal dose to rats of the test item was demonstrated to be greater than 2000 mg/kg bodyweight.
The test substance is in Category 3 according to the EPA Health Effects Test Guidelines OPPTS 870.1000 Acute Toxicity testing EPA 712-C-98-189 August 1998.