Registration Dossier

Administrative data

Description of key information

Four studies were performed to evaluate acute oral and dermal  toxicity of the test substance and a structural analogue to the rat (according or similar to OECD 401, 402). Neither the test substance nor the analogue induces any mortalities, abnormalities or clinical signs when applied oral or dermal. The LD50 for oral and dermal toxicity is considered to be > 5000 mg/kg bw and > 2000 mg/kg bw, respectively.

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:
comparable to guideline study with acceptable restrictions
Remarks:
no details to test item, some data concerning animals (breeder, acclimatization period) and enviromental conditions (humidity and air changes7h) are missing, frequency of observation not given, no details to autopsy result or any individual data
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: /
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 113 g male and 131 g female
- Fasting period before study: 18h
- Housing: singly
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: /

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): /
- Air changes (per hr): /
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: From: To:
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
2 % aqueous solution
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25%
- Amount of vehicle (if gavage): 20 ml/kg bw

MAXIMUM DOSE APPLIED: 5000 mg/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 per sex and dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: /
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and autopsy
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
no
Clinical signs:
no
Gross pathology:
no findings

No clinical symptoms were recorded and no deaths occurred during the 14 day observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) in rats is greater than 5 g/kg bw. Therefore, no indication for acute toxicity is indicated.
Executive summary:

The test substance was tested for its acute toxicity potential in the standard acute test method, similar to OECD 401.

Five male and female Sprague-Dawley rats were individually housed. The test substance was administered in a carboxymethyl cellulose vehicle as a limit dose of 5000 mg/kg bw.

Animals were observed for clinical signs and an autopsy was performed at the end of the 14 day observation period.

There were no clinical symptoms observed and no animal died during the study. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.

The acute oral median lethal dose (LD50) was greater than 5 g/kg body weight and the test substance is not considered acute toxic in rats.

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

Acute toxicity: via inhalation route

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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Further information are included as attachment in chapter 13 of the IUCLID dossier.
Reason / purpose:
read-across source
Reason / purpose:
read-across: supporting information
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute oral toxicity

The test substance was tested for its acute toxicity potential in the standard acute test method, similar to OECD 401.

Five male and female Sprague-Dawley rats were individually housed. The test substance was administered in a carboxymethyl cellulose vehicle as a limit dose of 5000 mg/kg bw.

Animals were observed for clinical signs and an autopsy was performed at the end of the 14 day observation period.

There were no clinical symptoms observed and no animal died during the study. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.

The acute oral median lethal dose (LD50) was greater than 5 g/kg body weight and the test substance is not considered acute toxic in rats.

In one acute toxicity tests in structurally analog substances in male and female Sprague-Dawley and Wistar rats, similar to OECD 401, no death occurred up to 15000 mg/kg bw.

Acute dermal toxicity

There are two acute dermal toxicity tests with structurally analog substances according to or similar to OECD 402 with male and female Wistar rats. The test substance was administered up to limit concentrations of 2000 and 5000 mg/kg bw.

No animals died during the study periods.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008, as amended for the thirteenth time in Regulation (EU) No 2018/1480. As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008.