Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From June 6 to 21, 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP study conducted in compliance with OECD Guideline No. 402 without deviation.

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:
OECD Guideline 402 (Acute Dermal Toxicity)
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
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
Remarks:
UK GLP Compliance Programme (inspected on March 07, 2005/ signed on June 09, 2005)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Appearance: White solid
- Storage condition of test material: Room temperature in the dark under nitrogen

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Ltd, Margate, Kent, England
- Age at study initiation: ca. 8–20 weeks
- Weight at study initiation: 210–354 g
- Fasting period before study: None
- Housing: The rats were housed individually from Day -1 in metal cages until Day 5 when they were returned to group housing.
- Diet: Standard laboratory rodent diet (Special Diet Services RM1(E) SQC expanded pellet), ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 40-70%
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: June 6, 2005 To: June 21, 2005

Administration / exposure

Type of coverage:
occlusive
Vehicle:
corn oil
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorso-lumbar region (One day prior to treatment, hair was removed with electric clippers)
- % coverage: ca. 50 mm x 50 mm (approximately 10% of total body surface area)
- Type of wrap: Treatment area was covered with porous gauze held in place with a non-irritating dressing, and further covered by a waterproof dressing encircled firmly around the trunk of the animal.

REMOVAL OF TEST SUBSTANCE
- Washing: Treatment area was washed with warm water (30-40 °C) to remove any residual test substance
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 3 mL/kg bw
- Concentration: 666.7 mg/mL
- Dose: 2000 mg/kg bw
- Constant volume or concentration used: Yes
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
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:
Mortality: Cages of rats were checked at least twice daily for mortalities.
Clinical signs: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only).
- Frequency of weighing: Bodyweight of each rat was recorded on Days 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: Yes; all animals were killed on Day 15 by carbon dioxide asphyxiation and a macroscopic examination was performed.
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
There were no deaths related to treatment in any animal.
Clinical signs:
There were no systemic responses to treatment in any animal.
Body weight:
All animals were considered to have achieved satisfactory bodyweight gains throughout the study.
Gross pathology:
No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.
Other findings:
None

Any other information on results incl. tables

There were no dermal reactions observed in any animal during the study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
Dermal LD50 Combined > 2000 mg/kg bw. Under the test conditions, the test material is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In an acute dermal toxicity study (limit study) performed according to the OECD guideline No. 402 and in compliance with GLP, a group of ten rats (five males and five females) received a single topical application of the test substance, formulated in corn oil at a dose level of 2000 mg/kg bw, for a duration of 24 hours. The animals were observed for mortality, clinical signs and body weight for 14 days and then necropsied for macroscopic observations.

There were no deaths and no systemic response to treatment in any animal throughout the study. No dermal reactions were observed in any animal during the study. All animals were considered to have achieved satisfactory bodyweight gains throughout the study. No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15. 

 

Dermal LD50 Combined > 2000 mg/kg bw.

 

Under the test conditions, the test material is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.