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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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP, no guideline followed but similar to the OECD 402 guideline with deviations.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
, less than 5 animals per dose (4 animals max. were used per dose). In the oldest study 2 dose levels were examined instead of 3 dose levels.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3 - 5 months
- Weight at study initiation: average 2.5 kg
- Diet: ad libitum, Rockland standard rabbit diet
- Water: ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
In the oldest study (1957), 2 doses were used, 0.10 mL/kg bw and 0.20 mL/kg bw of the undiluted test substance.
In the latest study (1974) 3 doses were used, 0.20 mL/kg bw, 0.40 mL/kg bw and 0.80 mL/kg bw of the undiluted test substance.
No. of animals per sex per dose:
In the oldest study (1957) 4 male animals per dose were examined.
in the latest study (1974) two dose groups consisted of 4 male animals per dose and one group with 2 animals (the group with the highest concentration examined)
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, indications on the skin, gross pathology
Statistics:
Thompson´s method of calculating LD50 was used.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
0.14 mL/kg bw
Based on:
test mat.
Remarks on result:
other: equivalent to LD50=127 mg/kg bw. The result was obtained in the oldest study (1957)
Sex:
male
Dose descriptor:
LD50
Effect level:
0.252 mL/kg bw
Based on:
test mat.
Remarks on result:
other: Equivalent to LD50=228 mg/kg bw. The result was obtained in the latest study (1974).
Mortality:
Oldest study (1957):
In the dose group 0.10 mL/kg bw no mortality was observed.
In the 0.20 mL/kg bw dose group mortality of 4/4 within 1 -3 days (100 % mortality)
Latest study (1974):
In the 0.20 mL/kg bw dose group mortality of 1/4
in the 0.40 mL/kg bw dose group mortality of 4/4 (100 % mortality)
In the 0.80 mL/kg bw dose group mortality of 2/2 (100 % mortality)
Clinical signs:
On the skin applied with the test substance marked skin necrosis was observed.
Symptoms as unsteady gait and lethargic were indicated in the later study (1974).
Gross pathology:
Oldest study (1957): lung hemorrhage, pale or yellow coloration of livers, pale yellow kidneys with potential hemorrhage.
Latest study (1974): by animals that died during the exposure/ observation period livers and kidneys were pale and mottled , lungs and spleens congested. No gross pathological indications were observed by survivors.

Applicant's summary and conclusion