Registration Dossier

Administrative data

Description of key information

A guideline conform key study according to OECD TG 401 is available regarding acute oral toxicity. At the limit dose of 2000 mg/kg body weight no mortality and no signs of clinical toxicity were observed. Recent scientific analysis of data from in vivo acute toxicity studies have shown that substances that are not toxic via the oral route with high certainty are also non-toxic via the dermal route. Based hereupon and in accordance with Commission Regulation (EU) 2016/863 and REACH Regulation (EC) 1907/2006 Annex VII and VIII 8.5.3. testing by the dermal route need bot be conducted as the registration substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route. Inhalation is no intended route of exposure.

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
Study period:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
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:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breeding
- Age at study initiation: male animales 7 weeks, female animals 8 weeks
- Weight at study initiation: male animales 186 +/- 3 g; female animals 176 +/- 5 g
- Fasting period before study: over night
- Housing: macrolon cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 hours periodically

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg body weight (limit dose)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, macroscopic pathology
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortalities and no clinical signs of toxicity observed
Mortality:
No mortality
Clinical signs:
No clinical signs of intoxication
Body weight:
Body weight development not affected
Gross pathology:
No macroscopic findings
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the test item in rats is greater 2000 mg/kg body weight. At this limit dose no mortality and no clinical signs of intoxication were observed in the 14 day observation period following oral application.
Executive summary:

The registration substance was tested for acute oral systemic toxicity in male and female Wistar rats. After application of 2000 mg/kg body weight (limit dose), no mortality and no clinical signs of intoxication occurred within the subsequent observation period of 14 days. Macroscopically visible changes were not observed during necropsy. Based on the results of this study the median lethal dose (LD50) of the registration substance in the rat is greater than 2000 mg/kg body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Data reliable and meet criteria for classification & labelling requirements.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

According to Commission Regulation (EU) 2016/863 and REACH Regulation (EC) 1907/2006 Annex VII and VIII 8.5.3 and supported by results from an OECD TG 401 guideline study which revealed a LD50 of greater 2000 mg/kg body weight, no classification according to GHS / CLP of the registration substance is warranted with regard to acute toxicity.