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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:
1990-10-11 - 1990-10-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
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): Jeffcat DMP
Specific details on test material used for the study:
- Name of test material (as cited in study report): 6398-14-20
- Physical state: clear, pale yellow liquid
- Analytical purity: responsibility of the Sponsor
- Lot/batch No.: #90-006
- Stability under test conditions: No apparent change in the physical state of the test article during administration
- Other: gravity: 0.852 g/ml

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hare-Marland, Hewitt, New Jersey
- Age at study initiation: young adult
- Weight at study initiation: Males 2.271-2.795 kg; Females: 2.092-2.420 kg
- Fasting period before study: no data
- Housing: 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 (e.g. ad libitum): Purina Rabbit Ration H.F. R, ad libitum,
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: min. 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C±3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12h dark/12h light


IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: trunk (clipped free of fur)
- Type of wrap if used: The animals were wrapped with rubber dam and an elastic bandage to retard evaporation.


REMOVAL OF TEST SUBSTANCE: no washing


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3000 mg/kg


Duration of exposure:
24h
Doses:
3000 mg/kg
No. of animals per sex per dose:
10 (5 ♀ and 5 ♂)
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once a day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
No data

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 000 mg/kg bw
Mortality:
Observation:
Females: 2/5 died during 1st day observation
Males: 3/5 died during 1st day observation
Clinical signs:
Decreased activity, decreased muscle tone, abnormal stance, abnormal gait, immediate post-dose vocalization, necrosis and sloughing of the skin at the application site were also observed throughout the study.
Body weight:
mean bodyweight of males : 2483g (initial) - 2719g (final)
mean bodyweight of females : 2304g (initial) - 2672.7g (final)
Gross pathology:
Necropsy of the animals dying on study included pale and/or mottled liver, dark red or pale lungs, mottled lungs, clear or red oral and/or nasal discharge and severe irritation of underlying muscle at the application site.
Terminal necropsy of the remaining animals revealed no visible lesions.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based upon the observations made in the acute dermal exposure toxicity study in rabbits where animals were exposed to 3000 mg/kg bw of '6398-17-20' (name indicated in the report), the estimated dermal LD50 was determined to be 3000 mg/kg. Based on these results and according to the criteria laid down in the CLP Regulation, the substance is not to be classified as acute dermal toxicant.