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Description of key information

The LD50 for acute oral toxicity was determined to be > 5000 mg/kg bw

The LD50 for acute dermal toxicity was determined to be > 2500 mg/kg bw

The LC50 (8h) for acute inhalation toxicity was determined to be > 2.33 mg/L air.

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:
12 Sept. 1973 to 03 Sept. 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
According to BASF-internal standard: 5 Sprague-Dawley rats (per sex and per dose) were exposed to the test substance via oral gavage at a dose of 5000 mg/kg bw. After an observation period of 7 days animals were necropsied and examined for clinical signs.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Name of the test substance used in the study report: Neozapongelb R (TDA) Chromium-1.2-complex

performed under old CAS 73297-13-9
new CAS 85029-58-9, same structure
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Mean body weight: males 176 g; females 166 g
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
Aqueous test substance preparation with CMC
Form of administration: suspension
Test concentration used: 16% (w/v)
Due to technical reasons, a higher test substance concentration (more than 16%) could not be administered.
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Feces brown coloured.
Gross pathology:
Nothing abnormal detected.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw

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:
11 Sept. 1973 to 03 Sept. 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
According to BASF-internal standard: 6 rats (per sex per dose) were exposed via dust inhalation for 8 h. LC50 was determined after 8 h of exposure.
GLP compliance:
no
Test type:
other: inhalation hazard test
Specific details on test material used for the study:
Name of the test substance used in the study report: Neozapongelb R (TDA) Chromium-1.2-complex

performed under old CAS 73297-13-9
new CAS 85029-58-9, same structure
Species:
rat
Sex:
male/female
Details on test animals or test system and environmental conditions:
Mean body weight: 201 g
Route of administration:
inhalation: dust
Duration of exposure:
8 h
Concentrations:
Mean concentration: 2.33 mg/L
No. of animals per sex per dose:
6 animals per sex per dose
3 animals per sex per control
Control animals:
other: air control
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2.33 mg/L air
Based on:
test mat.
Exp. duration:
8 h
Mortality:
None.
Clinical signs:
other: None.
Body weight:
Nothing abnormal detected.
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:
04 Oct. 1973 to 03 Sept. 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
According to D.N. Noakes and D.M. Sanderson: A Method for Determing the Dermal Toxicity of Pesticides. Brit. J. Ind. Med. 26, 59, 1969
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes
Specific details on test material used for the study:
Name of the test substance used in the study report: Neozapongelb R (TDA) Chromium-1.2-complex

old CAS 73297-13-9
new CAS 85029-58-9, same structure
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Mean body weight: males 135 g, females 121 g
Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
A 50% test substance concentration was used
Application area: 50 cm2 (average)
Duration of exposure:
24 h
Doses:
2500 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and local skin findings
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
During and after application as well as during the 14-day observation period the animals were vivacious.
Gross pathology:
Nothing abnormal detected
Other findings:
Local findings:
- After 24 hours all animals showed substance residues (light brown), reddening not visible
- After 8 days: no local effects observed in all animals, yellowish substance residues
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 500 mg/kg bw

Additional information

Acute oral toxicity:
In an acute oral toxicity study, Sprague-Dawley rats (5 per sex per group) were given a single dose of the test item in carboxymethyl cellulose (CMR) at a dose of 5000 mg/kg bw (BASF 1974). Due to technical reasons, a higher test substance concentration (more than 16%) could not be applied. No mortality was observed within 7 days and the LD50 was determined to be > 5000 mg/kg bw.

Acute inhalation toxicity:
In an acute inhalation toxicity study, rats (6 per sex per group) were exposed by inhalation route to the test item at a mean concentration of 2.33 mg/L for 8 hours. No deaths and no abnormalities to the animals were observed after the exposure period. The LC50 (8h) was determined to be > 2.33 mg/L.

Acute dermal toxicity:
In an acute dermal toxicity study, groups of Sprague-Dawley rats (5 animals per sex per group) were dermally exposed to the test substance as a 50% aqueous test substance preparation by single dose of 2500 mg/kg for 24 hours on clipped areas (about 50 cm²) of the back. Animals were observed for 14 days. After 24 hours all animals showed tan substance residues however reddening was not visible. After 8 days, yellowish substance residues were visible however no effects were observed on any of the animals. No mortality occurred within 14 days and the LD50 was determined to be > 2500 mg/kg.

Justification for classification or non-classification

Based on the available information classification for acute oral toxicity and acute dermal toxicity is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.