Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1976
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment: Non-GLP study; no data about purity and no certificate of analysis of the test substance; no details on age, gender, weight and strain of rats and housing conditions
Principles of method if other than guideline:
Standard acute method (limit test)
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): Dimetol
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
None
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
None
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
Total no. of animals = 10
Control animals:
no
Details on study design:
- Animals were observed for mortality and clinical signs of toxicity for 14 days.
- Necropsy performed: Yes
Statistics:
None
Preliminary study:
Not applicable
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
- 2/10 animals died on Day 1.
Clinical signs:
- At 2 h, lethargy, ataxia and loss of righting reflex were noted in animals.
- At 24 h, lethargy in 3/8 animals and piloerection in 2/8 animals were noted.
Body weight:
No data
Gross pathology:
At necropsy, lungs and stomach were red in 2 animals.
Other findings:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 for Dimetol is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the CLP Regulation.
Executive summary:

In an acute oral toxicity study, 10 rats were given a single oral dose of Dimetol at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs of toxicity for 14 days.

Two of the 10 rats died on Day 1. At 2 h, lethargy, ataxia and loss of righting reflex were noted in rats. At 24 h, lethargy in 3/8 rats and piloerection in 2/8 rats were noted. At necropsy, lungs and stomach were red in 2 rats.

The oral LD50 for Dimetol is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the CLP Regulation.

Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1969
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
Non-GLP study; no data about purity and no certificate of analysis of the test substance; effects on clinical signs, body weights and gross pathology were not reported; observation period: 5 days; no. of animals at highest dose level < 5; no details on the environmental conditions
Reason / purpose:
reference to other study
Principles of method if other than guideline:
Method: Groups of rats (2 or 5/sex/dose) were given a single oral dose of the test item at 4.0, 5.0, 5.5, 6.0 and 7.0 mL/kg bw in corn oil and then observed for mortality for 5 days.
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): DIMETOL
- Date received: 26 May 1969
- Physical state: Clear colourless liquid
Species:
rat
Strain:
other: CFE rats of Carworth strain
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 125-150 g
- Housing: Animals were housed in raised wire mesh cages.
- Fasting period before study: 18 h
- Diet: Lab Blox diet, ad libitum
- Water: Ad libitum
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
DOSAGE PREPARATION: Test material was diluted one part to five parts with corn oil (v/v) prior to dosing.
Doses:
4.0, 5.0, 5.5, 6.0 and 7.0 mL/kg bw
No. of animals per sex per dose:
7 mL/kg bw: 2/sex/dose
4.0, 5.0, 5.5 and 6 mL/kg bw: 5/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 5 days
Statistics:
LD50 value was calculated using the method of Litchfield and Wilcoxon (1949).
Preliminary study:
Not applicable
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5.82 mL/kg bw
Based on:
test mat.
95% CL:
5.35 - 6.32
Remarks on result:
other: equivalent to 4714 (4333-5119) mg/kg bw; calculated using the density of 0.81 g/L (literature)
Mortality:
- Mortalities were 0/10, 2/10, 3/10, 6/10 and 4/4 at 4.0, 5.0, 5.5, 6.0 and 7.0 mL/kg bw, respectively.
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data
Other findings:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 of DIMETOL is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the CLP Regulation.
Executive summary:

In an acute oral toxicity study, groups of CFE rats (2 or 5/sex/dose) were given a single oral dose of DIMETOL at 4.0, 5.0, 5.5, 6.0 and 7.0 mL/kg bw in corn oil. Animals were then observed for mortality for 5 days and LD50 value was calculated using Litchfield and Wilcoxon method (1949).

After 5 days, mortalities were 0/10, 2/10, 3/10, 6/10 and 4/4 at 4.0, 5.0, 5.5, 6.0 and 7.0 mL/kg bw, respectively. In this study, the combined oral LD50 of DIMETOL in rats was considered to be 5.82 (5.35-6.32) mL/kg bw [equivalent to 4714 (4333-5119) mg/kg bw; calculated using the density of 0.81 g/L (literature)]

The oral LD50 of DIMETOL is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the CLP Regulation.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion