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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:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given:comparable to guidelines/standards.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
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Reason / purpose:
read-across: supporting information
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given:comparable to guidelines/standards.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose:
read-across source
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
other: Noakes, DN, and Sanderson, DM (1969). A method for determining the dermal toxicity of pesticides. Br. J. Industr. Med., 26, 59-64.
GLP compliance:
no
Limit test:
yes
Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Manston, Kent
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1, 2, or 4 ml/kg
Duration of exposure:
24 hrs
Doses:
1, 2, 4 ml/kg
No. of animals per sex per dose:
2 animals of each sex per dose
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 mL/kg bw
Mortality:
No animals died during the study.

Mortality

Dose ml/kg

Males

Female

Total

1

0/2

0/2

0/4

2

0/2

0/2

0/4

4

0/2

0/2

0/4

Interpretation of results:
study cannot be used for classification
Conclusions:
The dermal LD50 for rats is > 4 ml/kg (~3400 mg/ kg bw).
Executive summary:

This study examined the acute toxicity of Dilutine M5 to rats via dermal exposure. 2 female and 2 male rats were exposed to 1, 2, or 4 ml/kg of undiluted test material dermally for 24 hrs. No rats died during the experiment. The dermal LD50 for rats is > 4 ml/kg (~3400mg/kg bw).

Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Noakes, DN, and Sanderson, DM (1969). A method for determining the dermal toxicity of pesticides. Br. J. Industr. Med., 26, 59-64.
GLP compliance:
no
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Manston, Kent

Administration / exposure

Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1, 2, or 4 ml/kg
Duration of exposure:
24 hrs
Doses:
1, 2, 4 ml/kg
No. of animals per sex per dose:
2 animals of each sex per dose

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 mL/kg bw
Mortality:
No animals died during the study.

Any other information on results incl. tables

Mortality

Dose ml/kg

Males

Female

Total

1

0/2

0/2

0/4

2

0/2

0/2

0/4

4

0/2

0/2

0/4

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
The dermal LD50 for rats is > 4 ml/kg (~3400 mg/ kg bw).
Executive summary:

This study examined the acute toxicity of Dilutine M5 to rats via dermal exposure. 2 female and 2 male rats were exposed to 1, 2, or 4 ml/kg of undiluted test material dermally for 24 hrs. No rats died during the experiment. The dermal LD50 for rats is > 4 ml/kg (~3400mg/kg bw).