Registration Dossier

Administrative data

Description of key information

In an acute oral study, rats (5/sex) received the substance by oral gavage at 5000 mg/kg bw. No effects on mortality, bodyweight or macroscopy were found after the 14 day observation period. On day 1 of the test hunched posture, piloerection and diarrhea were observed. The LD50 is > 5000 mg/kg bw (Safepharm 1985).

Based on the information in an abstract from 1974 the dermal LD50 is > 4000 mg/kg bw

As the substance does not show toxicity in the acute oral toxicity study, further testing via the dermal route was waived.

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:
30 October 1985 to 19 November 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
no data on purity
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
no data on purity of the tested substance
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna Ltd, Wyton, Huntingdon UK
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: 5-8 weeks
- Weight at study initiation: males 172-200 g; females 172-183 g
- Fasting period before study: overnight until 2 hours post dosing
- Housing: 5/sex/polypropylene cage
- Diet: Rat and Mice Expanded Diet no 1 (Special Diet Srvices Ltd, Witham, Essex UK) ad libitum):
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 °C
- Humidity (%): 40-65%
- Air changes (per hr): 15/hour
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 500 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL

Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males + 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations:clinical signs and mortality : after 1 and 4 hours and daily thereafter
- Body weight: on day 0, 7 and 14
- Necropsy of survivors performed: yes
Statistics:
NA
Preliminary study:
Hunched posture, piloerection and diarrhea on day 1 at 2000 and 5000 mg/kg bw
No mortality
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
Hunched posture, piloerection and diarrhea on day 1
Body weight:
within normal ranges
Gross pathology:
no effects
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the substance tested the LD50 is >5000 mg/kg bw.
Executive summary:

In an acute oral study, rats (5/sex) received the substance by oral gavage at 5000 mg/kg bw. No effects on mortality, bodyweight or macroscopy were found after the 14 day observation period. On day 1 of the test hunched posture, piloerection and diarrhea were observed. The LD50 is > 5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
worst case estimate as in the available studies limited information on purity is available

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:
supporting study
Study period:
1974
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
abstract
Qualifier:
no guideline followed
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
no data
Type of coverage:
not specified
Vehicle:
not specified
Duration of exposure:
4 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males
Control animals:
not required
Details on study design:
no data
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Based on:
act. ingr.
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the substance is > 4000 mg/kg bw
Executive summary:

Five male rats received a single dose of 4000 mg/kg bw. The LD50 of the substance is > 4000 mg/kg bw, when corrected for purity of the tested substance

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 000 mg/kg bw
Quality of whole database:
Not assignable, but in absence of effects in the oral study no further testing via the dermal route is considered necessary

Additional information

Based on the information available the substance does not need to be classified for acute toxicity according to Regulation (EC) No 1272/2008.

Justification for classification or non-classification