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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Restrictions: No guideline study, no GLP study, low number of animals, post exposure observation period 7 days, LD50 not calculated

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report Date:
1965

Materials and methods

Principles of method if other than guideline:
test method according to Hill, Ass. Food and Drug Off. 18, 1954
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity 88-97%, up to 5% water, up to 2% thiodiglycol

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
Rabbits initial bw 2.26-2.5 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Application of 0.05, 0.1 or 0.2 ml undiluted TS per kg bw (corresponding to 56, 112, 224 mg/kg bw; density 1.12 g/ml, on the clipped back (area 40-70 cm²); occlusive; animals immobilized; exposure duration 24 h; post exposure observation period 7 d; 3 rabbits per dose; necropsy performed.
Duration of exposure:
24 h
Doses:
56, 112, 224 mg/kg (= 0.05, 0.1, 0.2 ml/kg)
No. of animals per sex per dose:
3
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
none

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 112 - ca. 224 mg/kg bw
Mortality:
0.2 ml/kg (exposed area about 50 cm2): 2/2 (within 8 - 20 h)
0.1 ml/kg (exposed area about 48 - 76 cm2): 1/3 (within 8 - 20 h)
0.005 ml/kg (exposed area about 42 - 68 cm2): 0/3
Clinical signs:
0.2 ml/kg bw: no specific resorptive intoxication symptoms observed; necropsy: one rabbit with moderate congestion of the lung.
0.1 ml/kg bw: apathy, local reddening and edema; necropsy of this rabbit: atelectase of the lung, congestion of liver and kidney.
0.05 ml/kg bw: apathy, local inflammation; necropsy: no effects.
Slight decrease in bw of all survivors (ca. 100 g decrease).
Gross pathology:
0.1 ml/kg: atelectase of the lung, congestion of liver and kidney.
0.05 ml/kg bw: no effects.

Any other information on results incl. tables

Mortality:

 Dose  Exposed area  Mortality
 0.2 ml/kg  ca. 50 cm2  3/3 (within 8 - 20 h)
 0.1 ml/kg  ca. 48 - 76 cm2  1/3 (within 8 - 20 h)
 0.05 ml/kg  ca. 42 - 68 cm2  0/3

Applicant's summary and conclusion