Registration Dossier

Administrative data

Description of key information

LD50, oral, m/f > 5000 mg/kg bw
LD50, dermal, m/f > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Vehicle:
other: 25% in deionised water
No. of animals per sex per dose:
5 males and 5 females
Details on study design:
The application volume of 20 ml/kg body weight was administered in two sub-applications of 10 ml body weight in each case at an interval of approx. 30 minutes.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
As well as unspecific signs of intoxication the animals also exhibited diarrhoea. In addition, red discoloration of the hairless skin was observed. The substance was eliminated via the faeces and the urine, the urine still having a slight red colouration 14 days p.a.
Gross pathology:
Post-mortem examination of the animals killed at the end of the experiment revealed a pink colouration of the connective and fatty tissue, of the pancreas, the bladder, the testes and the uterus.
Interpretation of results:
other: not classified under Regulation 1272/2008
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The analogue substance was tested for acute oral toxicity following OECD 401. Under the experimental conditions the LD50 > 5000 mg/kg.
Executive summary:

The analogue substance was tested for acute oral toxicity following OECD 401. Under the experimental conditions the LD50 > 5000 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Type of coverage:
occlusive
Vehicle:
other: prepared with 0.9% NaCl solution in a ratio of 1g + 0.7 ml
Duration of exposure:
24h
No. of animals per sex per dose:
5 males and 5 females
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: 0Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Body weight:
no substance exposure related effects
Gross pathology:
The macroscopically determined findings among the animals killed at the end of the test revealed red discoloration of remaining animals were free from macroscopically visible peculiarities.
Other findings:
The visible areas of skin of some animals were discoloured red during the first week of testing. In addition, isolated cases of small wounds with scabs occurred in the region of the shorn area of skin in the female animals.The findings were reversible 9 days p.a.The remaining animals were free from macroscopically visible peculiarities
Interpretation of results:
other: not classified under Regulation 1272/2008
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The substance was tested for acute dermal toxicity following OECD 402. Under the experimental conditions the LD50 > 2000 mg/kg bw.
Executive summary:

The substance was tested for acute dermal toxicity following OECD 402. Under the experimental conditions the LD50 > 2000 mg/kg bw.

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

Additional information

The analogue substance was tested for acute oral and dermal toxicity in two in-vivo studies following OECD 401 and 402 (NONS dossier, 1988).

For the acute oral toxicity five males and five females of Wistar were dosed and the LD50, m/f > 5000 mg/kg bw.

No deaths or clinical signs related to substance exposure were recorded for the acute dermal toxicity test, with a LC50 > 2000 mg/kg.

Based on the read across considerations same results apply to Reactive Red 239:1.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:

For Acute toxicity oral route:

Category 1: ATE <= 5 mg/kg bw

Category 2: 5 < ATE <= 50 mg/kg bw

Category 3: 50 < ATE <= 300 mg/kg bw

Category 4: 300 < ATE <= 2000 mg/kg bw

The LD50 of the test substance was determined to be > 5000 mg/kg bw in the chosen reference test, which does not classified the substance.