Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 (rat; male/female)
Dermal LD50 > 2000 mg/kg bw (rat; male/female)

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: see 'Remark'
Remarks:
The study was conducted in compliance with GLP standards according to Guideline 84/449/EWG, B.1 and OECD 401 (1987). However, full study report is not available as the data is > 12 year old and summaries have been prepared using data provided by ECHA.
Qualifier:
according to guideline
Guideline:
other: 82/449/EWG, B.1, OECD 401 (1987)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Wistar Hoe: WISKf (SPF71)
Sex:
male/female
Route of administration:
oral: unspecified
Vehicle:
other: 10% suspension in Sesamol
No. of animals per sex per dose:
Male: 5
Female: 5
Control animals:
not specified
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
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:
other: Signs of toxicity related to dose level: No signs of poisoning occurred during the entire test period. Yellow discoloured faeces were observed from the 1st to 3rd day.
Gross pathology:
Effects on organs: No anomalies
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The study was carried out in compliance with GLP according to guideline 84/449/EWG, B.1 and OECD 401. The LD50 is > 2000 mg/kg bw.
Executive summary:

No systemic toxic effects were described after single oral application of the dose level 2000 mg/kg of the substance to rats. No signs of poisoning occurred during the entire test period. Yellow discoloured faeces were observed from the 1st to 3rd day.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
exposure considerations
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: The study was conducted in compliance with GLP standards according to Guideline OECD 402. However, full study report is not available as the data is > 12 year old and summaries have been prepared using data provided by ECHA.
Qualifier:
according to guideline
Guideline:
other: 84/449/EWG, B.3; OECD 402(1987)
GLP compliance:
yes
Limit test:
yes
Species:
rat
Strain:
Wistar
Vehicle:
other: angeteigt mit PE-Giykol 400 im Verhaltnis 1 g Substanz + 2 ml PEG 400
Duration of exposure:
24 h
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
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
Gross pathology:
No anomalies
Other findings:
Sign of toxicity (local):
No sign of poisoning occured during the entier test period. The skin of the animals was discoloured light yellow one day p.a.
Mortality did not occur
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The study was carried out in compliance with GLP according to guideline OECD 402. The LD50 is > 2000 mg/kg bw.
Executive summary:

No systemic toxic effects were described after single oral application at the dose level 2000 mg/kg in rats. No signs of poisoning occurred during the entire test period. The skin of the animals was coloured light yellow for one day after administration.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Oral exposure

In a guideline study (82/449/EWG, B.1, OECD 401 (1987) with acceptable restrictions (no purity of test material given) 5 male and 5 female rats were gavaged with test substance (calcium 4 -chloro-2 -(5 -hydroxy-3 -methyl-1-(3- sulfonatophenyl)pyrazol-4 -ylazo)-5 - ethylbenzenesulfonate).

The test substance was administered in 10% Sesamol suspension at concentration of 2000 mg/kg bw. The post exposure period was 14 days. The estimated oral LD50 value for male and female animals is > 2000 mg/kg bw. During the study no mortality or no signs of toxicity was observed.

The study of was selected as a key study and the result is used as a key value for hazard assessment and classification and labeling.


Justification for selection of acute toxicity – oral endpoint
The guideline compliant study.

Justification for selection of acute toxicity – inhalation endpoint
Toxicity unlikely based on oral and dermal study results. Not likely exposure route, since RMMs measures are in use.

Justification for selection of acute toxicity – dermal endpoint
The guideline compliant study.

Justification for classification or non-classification

Based on the results of acute toxicity studies no classification is proposed for acute toxicity according to the criteria of CLP regulation 1272/2008 and the EU directive 67/548/EEC.