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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

No adverse effects were observed in acute toxicity studies up to the highest dose level tested

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977/78
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
BASF-Test
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
no data
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
100% dispersion
Doses:
10000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
Statistics:
NA
Preliminary study:
NA
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
no effects
Clinical signs:
no effects
Body weight:
no data
Gross pathology:
no effects
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 for rats was determined to be > 10000mg/kg bw test material (> 2000 mg/kg bw active ingredient) under the conditions of the test. The substance is not classifiable according to CLP criteria.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977/78
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Smyth H.F. et al.: Am. Ind. Hyg. Ass. J. 23, 95-107 (1960)
GLP compliance:
no
Test type:
other: BASF Method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
no data
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
Inhalation of a saturated atmosphere at ambient temperature (20°C). To achieve saturation, 200L air per hour was fed through an approx. 5 cm deep layer of the product.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
7 h
Concentrations:
saturation concentration
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation, weekly weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology
Statistics:
NA
Preliminary study:
NA
Sex:
not specified
Dose descriptor:
LC0
Based on:
test mat.
Exp. duration:
7 h
Remarks on result:
other: no effect at saturation concentration
Mortality:
no deaths
Clinical signs:
other: no effects
Body weight:
no data
Gross pathology:
no effects
Interpretation of results:
GHS criteria not met
Conclusions:
7 hours inhalation of a with test item saturated atmosphere did not lead to any deaths in rats
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Type of coverage:
occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Details on dermal exposure:
50% concentration
Duration of exposure:
20 h
Doses:
2500 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
none
Clinical signs:
none
Body weight:
no data
Gross pathology:
no effects
Interpretation of results:
GHS criteria not met
Conclusions:
No adverse effects were noted at a limit dose of 2500 mg/kg bw
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

The acute oral toxicity of Vat Green 3 was tested in male and female rats at a limit dose level of 10000 mg/kg bw. The animals were observed for 14 days after test substance administration. No deaths or clinical signs of toxcity were observed throughout the study.

The LD50 was determined to be higher than 10000 mg/kg bw.

The acute inhalation toxicity of Vat Green 3 was tested in rats in a saturated atmosphere for 7 hours. The animals were observed for 14 days after test substance administration. No deaths or clinical signs of toxcity were observed throughout the study.

The acute dermal toxicity of Vat Green 3 was tested in male and female rats at a limit dose level of 2500 mg/kg bw. The animals were observed for 14 days after test substance administration. No deaths or clinical signs of toxcity were observed throughout the study.

The dermal LD50 was determined to be higher than 2500 mg/kg bw.

Justification for classification or non-classification

No adverse effects were observed in acute toxicity studies.