Registration Dossier

Administrative data

Description of key information

In the acute oral toxicity study with Solvent Violet 36, the LD50 was greater than 15000 mg/kg bw (discriminating dose). There are no studies available for acute inhalation or dermal toxicity.

A read across for acute dermal toxicity was conducted with Reinblau RLW (CAS 41611-76-1). In the study with Reinblau RLW a LD50 > 2000 mg/kg bw (discriminating dose) was found.

Therefore 2 valid studies (oral and dermal) are available to fulfill the requirement of point 8.5 of REACH Annex VIII.

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
A dose of 15000 mg/kg bw of the test substance was applied once to 10 female Wistar rats per gavage. The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation
period (once on Weekends and bank holidays). During inspections, the type, onset, duration, and intensity of clinical signs were recorded and dead animals removed if necessary. The animals were individually weighed at application at the end of the 14-day observation period.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Purity: technically pure
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
The acute toxicity experiment was carried out with SPF-bred Wistar rats (strain Wistar TNO W 74). At the start of study the female rats were about 14 weeks old and females 14weeks.
The rats were housed in groups of five animals each under conventional conditions in Makrolon Type-III cages on dust-free wood granules; they were exposed to a room temperature of 22 ± 1.5° C, a 12-hour light/dark cycle (artificial light from 7 a.m. to 7 p.m. CET), and relative humidity of about 60 ± 5 %.
During the study period the animals received feed and tap water ad libitum.
The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation period (once on Weekends and bank holidays). During inspections, the type, onset, duration, and intensity of clinical signs were recorded and dead animals removed if necessary. The animals were individually weighed at application and at the end of the 14-day observation period.
Route of administration:
oral: gavage
Vehicle:
peanut oil
Details on oral exposure:
The substance was formulated inpeanut oil and once administered to 10 female animals at a constant application volume of 30 ml/kg body weight. A rigid metal gavage was used for that purpose. The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation period (once on Weekends and bank holidays). During inspections, the type, onset, duration, and intensity of clinical signs were recorded and dead animals removed if necessary. The animals were individually weighed at application and at the end of the 14-day observation period.
Doses:
15000 mg/kg bw
No. of animals per sex per dose:
10 female rats/dose
Control animals:
no
Details on study design:
A dose of 15000 mg/kg bw of the test substance was applied once to 10 female Wistar rats per gavage. The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation
period (once on Weekends and bank holidays). During inspections, the type, onset, duration, and intensity of clinical signs were recorded and dead animals removed if necessary. The animals were individually weighed at application at the end of the 14-day observation period.
Key result
Sex:
female
Dose descriptor:
discriminating dose
Effect level:
15 000 mg/kg bw
Based on:
test mat.
Mortality:
None of the animals died.
Clinical signs:
The dose of 15000 mg/kg body eight, which was administered once, was tolerated without symptoms.
Body weight:
Body weight gain was not indluenced.
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 is greater than 15000 mg/kg bw (discriminating dose).
Executive summary:

A dose of 15000 mg/kg bw of the test substance was applied once to 10 female Wistar rats per gavage. The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation period. The dose of 15000 mg/kg body weight, which was administered once, was tolerated without symptoms by all female animals. The LD50 is greater than 15000 mg/kg bw (discriminating dose).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
15 000 mg/kg bw
Quality of whole database:
study well documented, meets generally accepted scientific principles, acceptable for assessment.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

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

Additional information

Justification for classification or non-classification

The acute oral toxicity is greater than 15000 mg/kg bw (discriminating dose). The acute dermal toxicity of the read-across substance is greater than 2000 mg/kg bw (discriminating dose).

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.