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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

ORAL
LD50 > 2000 mg/kg bw (male/female) rat, EU Method B.1

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:
13 December 1989 to 31 January 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was performed to a valid guideline and was conducted under GLP conditions. Furthermore, the data were submitted by another legal entity, under Directive 67/548/EEC, at least 12 years previously. The registrant has been granted permission to use the following information, which has been extracted from the ECHA databases, for REACH registration purposes. The data, based on the existing registration dossier, have already passed the check for completeness on the technical dossier. The data have therefore been assigned a reliability score of 1 in line with the criteria of Klimisch (1997).
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: unspecified
Vehicle:
other: Carboxymethyl Cellulose Sodium
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
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 body weight
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None of the animals died during the study.
Clinical signs:
other: No significant changes were observed. During the 14-day observation period, only mild soft stools were observed in one male rat from 50 minutes to 3 hours after the administration, and in one female rat at 3 hours after the administration.
Gross pathology:
No abnormalities were noted at necropsy of animals killed at the end of the study period.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, the LD50 of the test material was determined to be in excess of 2000 mg/kg bw.
Executive summary:

The acute toxicity of the test material was investigated, by the oral route, in a study which was conducted under GLP conditions and in accordance with the standardised guideline EU Method B.1.

During the study 5 male and 5 female rats were orally administered with 2000 mg/kg bw of the test material. Following administration, the animals were observed for a 14 day period; body weights and clinical signs were recorded. At the end of the study, the animals were submitted for necropsy.

None of the animals died during the study and no significant signs of toxicity were noted. All animals showed expected gains in bodyweight over the study period and no abnormalities were observed at necropsy.

Therefore, under the conditions of the study, the LD50 of the test material was determined to be in excess of 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The study was assigned a reliability score of 1 in accordance with the principles for assessing data quality as set forth in the publication by Klimisch et al (1997). The quality of the database is considered to be high.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral

The acute toxicity of the test material was investigated, by the oral route, in a study which was conducted under GLP conditions and in accordance with the standardised guideline EU Method B.1.

During the study 5 male and 5 female rats were orally administered with 2000 mg/kg bw of the test material. Following administration the animals were observed for a 14 day period; body weights and clinical signs were recorded. At the end of the study the animals were submitted for necropsy.

None of the animals died during the study and no significant signs of toxicity were noted. All animals showed expected gains in bodyweight over the study period and no abnormalities were observed at necropsy.

Therefore, under the conditions of the study, the LD50 of the test material was determined to be in excess of 2000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
Only one study is available.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance does not require classification with respect to acute toxicity.

In accordance with the criteria for classification as defined in Annex VI, Directive 67/548/EEC (DSD), the substance does not require classification with respect to acute toxicity.