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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:
weight of evidence
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, but considered sufficiently reliable for the purpose of hazard assessment.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1975
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Principles of method if other than guideline:
Method according to the typical testing for acute dermal toxicity in a limit test: topical application of substance on guinea-pigs at one high dose.
GLP compliance:
no
Remarks:
(pre-GLP)
Species:
guinea pig
Strain:
not specified
Details on test animals and environmental conditions:
No data
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw

Duration of treatment / exposure:
Single treatment (24 h exposure)
Observation period:
14 days
Number of animals:
Total: 10 animals
Details on study design:
No data
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24 h
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
- One mortality was observed
- No signs of systemic toxicity were noted during the observation period.
- Dermal reactions: slight redness in 4 and slight edema in 1 animal.
Other effects:
- No other clinical signs were observed

Acute dermal LD50 of test material was higher than 5000 mg/kg bw

Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, the test substance induced slight to moderate skin irritation in guinea-pigs.
Executive summary:

In an acute dermal toxicity study (limit test), ten guinea-pigs were given a single dermal application of the test material at a dose level of 5000 mg/kg bw. Animals were observed for mortality and clinical signs for 14 days.

One mortality occurred during the study. No clinical signs were observed. Slight redness was observed in 4 animals and slight edema in another one.

Under the test conditions, the test substance induced slight to moderate skin irritation in rabbits.

This study was conducted according to a non-standard method and adequate scoring of skin effects was not provided, therefore it was not possible to take a decision on the classification based solely on this study.

Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Semi-solid
Details on test material:
- Description: A dark brown, semi-solid mass

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 h
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
Total = 10
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Clinical observations, observations for mortality and toxic effects were made daily for 14 days
- Necropsy of survivors performed: No data
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 1/10 death
Mortality:
One mortality was observed.
Clinical signs:
- No signs of systemic toxicity were noted during the observation period.
- Dermal reactions: slight redness in 4 and slight edema in 1 animal.
Body weight:
No data.
Gross pathology:
No data.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the dermal LD50 for the test substance is higher than 5000 mg/kg bw in guinea-pigs. Therefore, the test substance is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In an acute dermal toxicity study (limit test), ten guinea-pigs were given a single dermal application of the test material at a dose level of 5000 mg/kg bw. Animals were observed for mortality and clinical signs for 14 days.

One mortality occurred during the study. No clinical signs were observed. Slight redness was observed in four animals and slight edema in another one. In this study, the dermal LD50 of Tabac absolute was higher than 5000 mg/kg bw in guinea-pigs.

Under the test conditions, the dermal LD50 for test substance is higher than 5000 mg/kg bw in guinea-pigs. Therefore, the test substance is not classified

according to the annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.