Registration Dossier

Administrative data

Description of key information

The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated from the flow chart in Appendix 1 (OECD 423) as being greater than 2500 mg/kg bodyweight. The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.

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:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bantin & Kingman, Hull, UK.
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 169 - 186g
- Fasting period before study:
- Housing: Groups of 3 in suspended solid floor polypropylene cages with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 7 and 14 th day
- Necropsy of survivors performed: yes
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Mortality:
None
Clinical signs:
On the day of dosing and up to 24 hours after dosing: hunched posture, lethargy, ataxia, decreased respiratory rate, ptosis, occasional body tremors, laboured respiration, exophthalmos and pilo-erection. All animals appeared normal two days after dosing.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated from the flow chart in Appendix 1 (OECD 423) as being greater than 2500 mg/kg bodyweight.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable (Klimisch score 1) study performed with the registered substance. The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII, Section 8.5., of Regulation (EC) No. 1907/2006.

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)
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bantin & Kingman, Hull, UK.
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: least 200g
- Housing: Individually during exposure and in gropus of 5 by sex for the remainder of the study
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15 changes
- Photoperiod (hrs dark / hrs light): 12 hours light and dark

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Shorn skin
- % coverage: approx. 10% of the total body surface area
- Type of wrap if used: Self adhesive bandage


REMOVAL OF TEST SUBSTANCE
After the 24-hour contact period, treated skin and surrounding hair wiped with distilled water

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths
Clinical signs:
No signs of systemic toxicity
Body weight:
Animals showed expected gains in bodyweight over the study period
Gross pathology:
No abnormalities were noted on necropsy
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable (Klimisch score 1) study performed with the registered substance. The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII, Section 8.5., of Regulation (EC) No. 1907/2006.

Additional information

Justification for classification or non-classification

No effects were observed up to 2500 mg/kg b.w. in an acute oral toxicity study and up to 2000 mg/kg b.w. in a dermal acute toxicity study (semiocclusive - fixed dose). The result of the acute toxicity testing do not warrant classsification for acute toxicity.