Registration Dossier

Administrative data

Description of key information

Several valid acute oral toxicity studies according or similar to OECD guideline 401 are available. The LD50 value in all studies was greater than 5000 mg/kg bw (discriminating dose).

In a valid acute inhalation study according to OECD guideline 436 a LC50 greater than 5.04 mg/l (discriminating dose) was determined.

No study for acute dermal toxicity is available: According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure’. The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Five male and five female rats received a single dose of 5000 mg/kg bw Resolin Rotviolett FBL fl., 3. Umstellung by gavage. After the application the animals were observed for mortality, clinical signs and body weight for 14 days. A necropsy was performed on the surviving animals at the end of the study.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
The acute toxicity experiment was carried out with SPF-bred Wistar rats (strain Bor: WISW (SPF Cpb). At the start of study the male rats were about 9 weeks old and females 14 weeks; the mean initial weight of males was 183 and that of females 175 g.
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 ± 2° C, a 12-hour light/dark cycle (artificial light from 6 a.m. to 6 p.m. CET), and relative humidity of about 50 ± 10 %.
During the study period the animals received tap water ad libitum. Feed was withdrawn from approx. 16 hours prior to until approx. 4 hours after application. The other time it was available ad libitum.
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The test substance was prepared immediately before the application.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female rats/dose
Control animals:
no
Details on study design:
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, after one week and at the end of the 14-day observation period. All animals which died intercurrent or were sacrificed at the end of study were necropsied.
Key result
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
none of the rats died.
Clinical signs:
No signs of poisoning were observed.
Body weight:
Body weight gain was not affected
Gross pathology:
No adverse findings were observed.
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 was greater than 5000 mg/kg bw (discriminating dose).
Executive summary:

A single dose of 5000 mg/kg bw of the test substance was applied to 5 male and 5 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 5000 mg/kg body weight was tolerated without adverse effects by all male and female animals.

No adverse gross pathological findings were observed. The LD50 is greater than 5000 mg/kg bw (discriminating dose).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Scientifically acceptable and well documented.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
GLP guideline study

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

According to the acute oral toxicity studies the LD50 is greater than 5000 mg/kg bw (discriminating dose) and the acute inhalation LC50 value is greater 5.04 mg/L (discriminating dose).

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

No study for acute dermal toxicity is available: According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure’. The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification.