Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 12, 2012 - December 12, 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

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
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): NOPCOTE 1661
- Physical state: Clear, light yellow solution
- Purity: 46%
- Lot/batch No.: 79389
- Expiration date of the lot/batch: 11 January 2013
- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld.- Age at study initiation: Young adult rats.- Weight at study initiation: Males: 231-242 g, Females: 213-234 g- Housing: Individual caging.- Diet (e.g. ad libitum): Ad libitum.- Water (e.g. ad libitum): Ad libitum.- Acclimation period: 6 days.ENVIRONMENTAL CONDITIONS- Temperature (°C): 20.6 – 25°C.- Humidity (%): 30 - 54 %.- Air changes (per hr): 15-20 air exchanges/hour .- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE- Area of exposure: back of the animals.- % coverage: 10% of the total body.- Type of wrap if used: Sterile gauze pads were placed on the skin to cover the test item. These gauze pads were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was then wrapped with semi occlusive plastic wrap for 24 hours.REMOVAL OF TEST SUBSTANCE- Washing (if done): The area of skin treated with the test item was washed with water of body temperature.- Time after start of exposure: 24 hoursTEST MATERIAL- Concentration: Purity factor of 2.18 to the dry content of the test item was used
Duration of exposure:
24 hour
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals/sex
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days- Frequency of observations and weighing: Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. - Necropsy of survivors performed: Yes, gross macroscopic examination was performed on all animals at the end of the 2-week observation period (Day 14).

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:
Administration of the test item did not cause mortality.
Clinical signs:
No clinical signs were observed after treatment or during the 14 day observation period.
Body weight:
The body weight and body weight gain of surviving animals did not show any test item-related effect.
Gross pathology:
No macroscopic effects were observed at necropsy.
Other findings:
Local dermal signs: Multifocal erythema in different diameters from 2 – 4 mm was noted in 4/5 males and 3/5 females which was reversible within 72 hours. In case of one male, a wound covered with scab later was observed from Day 2 to Day 9. Yellow discoloration of the fur was observed at the outskirt of the exposed surface in 5/5 males and 5/5 females.

Any other information on results incl. tables

Experimental results are included in the tables which contains the document attached ("Attached background material").

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 value of the test substance was >2000 mg/kg bw in male and female rats.
Executive summary:

The acute dermal toxicity of test substance was performed according to OECD 402 Guideline and EU B.3 Method in male and female rats. A limit test was carried out at 2000 mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was applied under semi-occlusive conditions as supplied as a single dermal 24-hour exposure followed by a 14‑day observation period. No treatment related effects were observed on mortality, clinical signs, body weight and necropsy. Multifocal erythema in different diameters were noted which were reversible within 72 hours. In case of one male, a wound covered with scab later was observed from day 2 to 9. Yellow discoloration of the fur was observed at the outskirt of the exposed surface in all animals. The acute dermal median lethal dose (LD50) of the test substance was found to be higher than 2000 mg/kg bw in male and female rats.