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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 17, 1998 - July 31,1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study is perfomed similar to to the OECD 402 guideline "Acute Dermal Toxicity", but not under GLP. Report is well documented, and the design is considered scientifically accepted.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 180-415
- Physical state: liquid
- Analytical purity: no data
- Lot/batch No.: no data
- Stability under test conditions: no data
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, Texas, USA
- Age at study initiation: young adult
- Weight at study initiation: male: 2.20 - 3.05 kg; female : 2.20 - 3.00 kg
- Housing: individually, in suspended wire bottom galvanized steel gages
- Diet (e.g. ad libitum): Purina rabbit chow, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: one week plus

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: no data (abraded skin)
- % coverage: less than 30% of the body surface
- Type of wrap if used: polyethylene film, secured in place with an adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently wiped with a clean cloth
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.95 ml/kg
- Concentration (if solution): 100% (undiluted)
Duration of exposure:
24 hours
Doses:
2010 mk/kg
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:
Mortality: frequently on the day of treatment and at least once daily thereafter for 14 days;
Individual body weights: on Day 0, 7, and 14;
Observations for Erythema and Eschar formation / Edema formation and any other dermal defects or irritation: immediately after the 24 hours exposure;
Gross necropsy examination at termination of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: body weight, skin irritation

other: SCORING SYSTEM: The scoring criteria as described by Draize. Erythema and Eschar formation / Edema formation
Statistics:
Not relevant

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 010
Remarks on result:
other: No mortality noted at this dose level
Mortality:
There were no deaths during the study in the 5 males and 5 females dosed with the test article.
Clinical signs:
Skin irritation: the average erythema and edema scores at 24 hours were 1.4 and 0.4 resp.
Body weight:
Normal increase on Day 14.
Gross pathology:
No observable abnormalities in any of the animals.
Other findings:
Not reported.

Applicant's summary and conclusion

Interpretation of results:
other: Not Classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
This study found no effects that related to acute dermal toxicity in rabbits after administrating a single dose of 2010 mg/kg. No deaths occurred during the study. The acute dermal LD50 for actual undiluted 180-415 as indicated by the data in this study is greater than 2010 mg/kg when applied to the abraded skin of albino rabbits. Based on these results and according to EU criteria the test substance does not need to be classified as acute toxic (dermal) according to the classification criteria outlined in 67/548/EEC and 1272/2008.
Executive summary:

An acute dermal toxicity study was conducted similar to OECD guideline 402, using 5 male and 5 female New Zealand White rabbits. The test material, 180-415, a clear yellow liquid, was administered undiluted in a single dose of 2010 mg/kg (1.95 ml/kg) on the lightly abraded skin of the rabbits, and then occluded for 24 hours. Frequency of observations during 14 days was as follows: Mortality: frequently on the day of treatment and at least once daily thereafter for 14 days; Individual body weights: on Day 0, 7, and 14; Observations for erythema and eschar formation / edema formation and any other dermal defects or irritation: immediately after the 24 hours exposure; Gross necropsy examination at termination of the study. There were no deaths during the study. The average skin erythema and edema scores at 24 hours were 1.4 and 0.4 resp. The animals gained weight in a normal manner. No observable abnormalities in any of the animals at gross pathology examination. The acute dermal LD50 for actual undiluted 180-415 as indicated by the data in this study is greater than 2010 mg/kg when applied to the abraded skin of albino rabbits. Based on these results and according to EU criteria the test substance does not need to be classified as acute toxic (dermal) according to the classification criteria outlined in 67/548/EEC and 1272/2008.