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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 deaths were observed up to oral dose levels of 10000 mg/kg bw and dermal dose levels of 2500 mg/kg bw in rats or at inhalational exposure of a saturation concentration of 0.32 mg/L air for 4 hours or at saturation concentration for 8 hours.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
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 401 (Acute Oral Toxicity)
Version / remarks:
BASF internal guidelines followed
GLP compliance:
no
Test type:
other: BASF method
Limit test:
no
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:
CMC (carboxymethyl cellulose)
Doses:
10000 mg/kg
No. of animals per sex per dose:
no data
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
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
no effects
Clinical signs:
other: no effects
Gross pathology:
no effects
Interpretation of results:
GHS criteria not met
Conclusions:
acute oral LD50 in rats is higher than 10000 mg/kg bw, no labelling necessary
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
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 401 (Acute Oral Toxicity)
Version / remarks:
BASF internal guidelines followed
GLP compliance:
no
Test type:
other: BASF method
Limit test:
no
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:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 35%
Doses:
8000 mg/kg
No. of animals per sex per dose:
no data
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
Dose descriptor:
LD50
Effect level:
> 8 000 mg/kg bw
Based on:
test mat.
Mortality:
no effects
Clinical signs:
other: dyspnea, apathia, ataxia, diarrhea, bad general condition green discolouration of faeces
Gross pathology:
acute cordial dilation, congestivw hyperaemia, diarrheic intestinal content
Interpretation of results:
GHS criteria not met
Conclusions:
acute oral LD50 in rats is higher than 8000 mg/kg bw, no labelling necessary
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Principles of method if other than guideline:
Method: other: BASF-Test
GLP compliance:
no
Test type:
other: BASF 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:
inhalation: aerosol
Type of inhalation exposure:
not specified
Vehicle:
air
Remarks:
saturated with test item at 20°C
Details on inhalation exposure:
Inhalation by means of vapuor saturated at 20°C for 4 hours. To achieve saturation, air was fed through an approx. 5 cm deep layer of the product.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
saturation concentration
No. of animals per sex per dose:
12 rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily observation
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, necropsy
Statistics:
NA
Preliminary study:
NA
Sex:
not specified
Dose descriptor:
LC50
Effect level:
> 0.32 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: technically highest concentration in air
Mortality:
no deaths
Clinical signs:
other: no effects
Body weight:
no data
Gross pathology:
no effects
Interpretation of results:
GHS criteria not met
Conclusions:
The 4-h LC50 in rat was determined to be > 0.32 mg/L air which was the technically possibly highest concentration.
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Principles of method if other than guideline:
Method: other: BASF-Test
GLP compliance:
no
Test type:
other: BASF 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:
inhalation: aerosol
Type of inhalation exposure:
not specified
Vehicle:
air
Remarks:
saturated with test item at 20°C
Details on inhalation exposure:
Inhalation by means of vapuor saturated at 20°C for 8 hours. To achieve saturation, air was fed through an approx. 5 cm deep layer of the product.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
8 h
Concentrations:
saturation concentration
No. of animals per sex per dose:
12 rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily observation
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, necropsy
Statistics:
NA
Preliminary study:
NA
Sex:
not specified
Dose descriptor:
LC0
Based on:
test mat.
Exp. duration:
8 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:
8 hours inhalation of a saturated athmosphere did not lead to any deaths in rats (0/12)
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:
1976
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:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
no data
Type of coverage:
not specified
Vehicle:
water
Details on dermal exposure:
50% aqueous paste
Duration of exposure:
20 hours
Doses:
2500 mg/kg bw
No. of animals per sex per dose:
no data
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: clinical signs daily
- Necropsy of survivors performed: yes
Statistics:
NA
Preliminary study:
NA
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Mortality:
no deaths
Clinical signs:
other: no effect
Gross pathology:
no effect
Interpretation of results:
GHS criteria not met
Conclusions:
acute dermal LD50 in rats is higher than 2500 mg/kg bw
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for classification or non-classification