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Administrative data

Description of key information

Data available includes an acute oral toxicity study provided by ECHA and an acute dermal toxicity study (conducted to OECD guidelines and GLP) as the relevant second exposure route.

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:
other: Data migrated from NONS with permission to refer granted by ECHA.
Qualifier:
according to
Guideline:
other: 92/69/EEC
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
794 mg/kg bw
Based on:
not specified
95% CL:
>= 483 - <= 1 305
Mortality:
2000 mg/kg bw: 5/5
1000 mg/kg bw: 2/5
Gross pathology:
No treatment-related macroscopic effects observed
Interpretation of results:
Category 4 based on GHS criteria
Remarks:
in accodance with CLP regulation (1272/2008/EC, as amended))
Conclusions:
Based on data provided by ECHA, the acute oral LD50 value is 794 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
794 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:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Remarks:
CD(SD)BR/VAF Plus
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Kingston (Stone Ridge, NY)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Males 6 to 7 weeks and females 7 to 8 weeks
- Weight at study initiation: Males 162 to 191g and females 161 to 170g
- Fasting period before study: None
- Housing: Singly housed in suspended stainless steel wire mesh cages.
- Diet (e.g. ad libitum): Certified rodent diet freely available
- Water (e.g. ad libitum): Water available freely
- Acclimation period: 5 days ahead of study initiation

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 54 to 60%
- Air changes (per hr): Not detailed
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Not detailed (applied to dorsal surface)
- % coverage: Not detailed
- Type of wrap if used: Occlusive wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes (running water)
- Time after start of exposure: After 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw applied directly


Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At least once daily
- Necropsy of survivors performed: yes
- Other examinations performed: body weight
Statistics:
Not applicable to study design
Preliminary study:
Not conducted
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
No mortality was observed
Clinical signs:
No toxicologically significant clinical signs were observed
Body weight:
No toxicologically significant effects on bodyweight were observed
Gross pathology:
No toxicologically significiant findings were noted at necropsy
Interpretation of results:
GHS criteria not met
Conclusions:
A reliable guideline study indicates that the test material is unlikely to cause dermal toxicity or skin irritation after exposure to the substance, with an LD50 value > 2000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

An acute toxicity study by the inhalation route is not required as the requirements for a second exposure route (in addition to the oral route) have been met by performance of an acute dermal toxicity study.

Justification for classification or non-classification

In the acute oral toxicity study provided by ECHA, the LD50 value of 794 mg/kg bw indicates that classification as Acute Toxicity Category 4 (harmful if swallowed) is appropriate (LD50 < 300 and </= 2000 mg/kg bw). This is in accordance with the CLP Regulation (EC No. 1272/2008, as amended). This classification already appears in Annex VI of CLP.

With regards to the acute dermal toxicity study, there were no toxic or irritant effects observed with the LD50 > 2000 mg/kg bw. Accordingly the substance would not be classified in accordance with the CLP regulation (EC No. 1272/2008, as amended).