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Administrative data

Description of key information

Acute oral toxicity:
Rat (Wistar) m/f; LD50 > 2000 mg/kg bw [EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method), GLP]
Acute dermal toxicity:
Rat (Wistar) m/f; LD50 ≥ 2000 mg/kg bw (24h) [EU Method B.3, GLP]

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
not specified
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: unspecified
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
4 %
Doses:
Male: 2000 mg/kg bw
Female: 2000 mg/kg bw
No. of animals per sex per dose:
Male: number of animals 3
Female: number of animals 3
Control animals:
not specified
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
not specified
Mortality:
Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
No clinical signs have been observed during the test.
Body weight:
No changes have been noted.
Gross pathology:
No effects on organs observed.
Other findings:
No other findings reported.
Interpretation of results:
not classified
Remarks:
Criteria used for interpretation of results: EU-GHS
Conclusions:
LD50 (rat) > 2000 mg/kg bw
The test substance showed no oral acute toxicity under the conditions of the test.
Executive summary:

The acute oral toxicity of the test substance has been determined in a GLP test with rats according to EU Method B.1 tris in a limit test. The LD50 value was > 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
The data has been extracted from ECHA databases. The files were first migrated from the SNIF (Structured Notification Interchange Format) format (used under Directive 67/548/EEC) into the IUCLID 5 format (used under the REACH Regulation) and represent all of the information that ECHA currently holds on this endpoint, which were submitted in the framework of a notification at least 12 years previously (as per Article 25(3)) for the substance with the same EC number for which you inquired.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Type of coverage:
semiocclusive
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
4 %
Duration of exposure:
24 h
Doses:
Male 2000 mg/kg bw
Female 2000 mg/kg bw
No. of animals per sex per dose:
Male 2000 mg/kg bw; Number of animals: 5
Female 2000 mg/kg bw; Number or animals: 5
Control animals:
not specified
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
not specified
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
No clinical signs have been observed during the test.
Body weight:
Two female animals lost weight during the first week of observation.
Gross pathology:
No effects on organs observed.
Other findings:
No other findings reported.
Interpretation of results:
not classified
Remarks:
Criteria used for interpretation of results: EU-GHS
Conclusions:
LD50 > 2000 mg/kg bw
The test substance showed no dermal acute toxicity under the conditions of the test.
Executive summary:

The acute dermal toxicity of the test substance has been determined in a GLP test with rats (limit test) according to EU Method B.3. The LD50 value was > 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
The data has been extracted from ECHA databases. The files were first migrated from the SNIF (Structured Notification Interchange Format) format (used under Directive 67/548/EEC) into the IUCLID 5 format (used under the REACH Regulation) and represent all of the information that ECHA currently holds on this endpoint, which were submitted in the framework of a notification at least 12 years previously (as per Article 25(3)) for the substance with the same EC number for which you inquired.

Additional information

Acute oral toxicity:

The acute oral toxicity of the test substance has been determined in a GLP compliant limit test with rats according to EU Method B.1 tris, resulting in a LD50 > 2000 mg/kg bw and therefore the test substance does not need to be classified according to Regulation 1272/2008/EC.

Acute dermal toxicity:

The acute dermal toxicity of the test substance has been determined in a GLP compliant limit test with rats according to EU Method B.3, resulting in a LD50 > 2000 mg/kg bw and therefore the test substance does not need to be classified according to Regulation 1272/2008/EC

Justification for classification or non-classification

Acute oral toxicity:

The test material does not meet the criteria for classification and will not require labelling for oral toxicity in accordance with European Regulation (EC) No. 1272/2008.

Acute dermal toxicity:

The test material does not meet the criteria for classification and will not require labelling for dermal toxicity in accordance with European Regulation (EC) No. 1272/2008.