Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20/09/1991 - 31/12/1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
- Expiration date of the lot/batch:
- Purity test date:
- Appearance : yellow liquid


STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
- Stability under test conditions: There was no apparent change in the physical appearance of the test articles during administration.
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: All test articles were dosed as received from the sponsor
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:

FORM AS APPLIED IN THE TEST (if different from that of starting material)

TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)

OTHER SPECIFICS:

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Supplier : CAMM Research Lab Animals
- Females (if applicable) nulliparous and non-pregnant: NA
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 1.814 to 3.188 kg
- Fasting period before study: No
- Housing: Rabbits were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Animal Resources, National Research Council.
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: Minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): relative humidity of 30 to 70%
- Air changes (per hr): NA
- Photoperiod (hrs dark / hrs light): 12/12

Rationale for Test System: The albino rabbit is preferred because of its size, skin permeability and extensive database.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Approximately 24 hours before testing, fur was Performance: clipped from the dorsal area of the trunk of the test animals.

The test article was applied directly onto the exposed intact skin of the animals taking care to spread the substance evenly over the entire area. A square gauze patch was placed on the animals to cover the dosed area. The animal.s were wrapped with rubber dam and an elastic bandage to retard evaporation.

The test article was held in contact with the skin for twenty-four hours.

Following the twenty-four hour period of exposure, the wrappings were removed and the skin sites were wiped with water and gauze to remove any residual test article.

Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
10 : 5 males and 5 females
Control animals:
no
Details on study design:
Rationale for Dose Selection: As required by the regulatory agencies

Observations were recorded daily through Day 14.
Body weights were recorded at initiation and on Days 7 and 14.
All rabbits were sacrificed by a lethal injection on Day 14 and a gross necropsy was performed.
Statistics:
NA

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 mortalities were recorded.
Clinical signs:
No clinical signs observed
Body weight:
No changes in body weight gain.
Gross pathology:
No visible lesions were observed.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The LD50 of the test item is greated than 2000 mg/kg bw.
Executive summary:

In a Dermal Limit Test (Vincent B. Ciafalo, 1992), performed according to national standard methods and in compliance with GLP, one group of 10 rabbits (5 males and 5 females) per study was exposed to the test article at 2000 mg/kg during 24 hours in a semi-occlusive system.

Animals were observed for clinical signs and mortality once daily for fourteen days.

No clinical signs, no mortalities and no lesions at gross necropsy were observed.

Therefore the LD50 of the test item is greater than 2000 mg/kg bw.

Butyl-NENA is classified as Category 5 accordign to the GHS criteria.