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Administrative data

Description of key information

Female rats (n=5) received a single oral dose of 2000 mg/kg bw of the test substance. No effects on clinical signs, body weight and macroscopic examinations were found. No mortality was observed. The LD50 is > 2000 mg/kg bw (Harlan 2012g).
Groups of 5 rats/sex received a dermal application of 2000 mg/kg test substance during 24 hours under semi-occlusion. No effects other than slight irritation were found during the 14 day observation period. The dermal LD50 of the test substance is > 2000 mg/kg bw (Harlan 2013d)

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:
21-08-2012 to 12-09-2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study under GLP
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 152-160 g
- Fasting period before study: 24 hours before dosing and 3-4 hours thereafter
- Housing: 4/cage in solid-floor polypropylene cages furnished with woodflakes
- Diet: 2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK ad libitum
- Water: ad libitum
- Acclimation period: >5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 30-70%
- Air changes (per hr): >15
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
DOSE VOLUME APPLIED: 10 mL/kg

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
1 female in the pre-test (2000 mg/kg bw), 4 females in the main study
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality twice daily; body weight on day 0 (before treatment), day 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs ½, 1, 2, and 4 hours after dosing and daily thereafter
Statistics:
NA, limit test
Preliminary study:
No mortality at 2000 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
none
Body weight:
within normal ranges
Gross pathology:
no effects
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 after oral application of the test substance is > 2000 mg/kg bw
Executive summary:

Female rats (n=5) received a single oral dose of 2000 mg/kg bw of the test substance. No effects on clinical signs, body weight and macroscopic examinations were found. No mortality was observed. The LD50 is > 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Study with the test substance according to the guideline and under GLP. The LD50 is > 2000 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
Study period:
17-04-2013 to 01-05-2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to the guideline under GLP
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. certificate)
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: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 152-160 g
- Housing: 1/cage in solid-floor polypropylene cages furnished with woodflakes during application, 5/sex/cage thereafter
- Diet: 2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK ad libitum
- Water: ad libitum
- Acclimation period: >5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 30-70%
- Air changes (per hr): >15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
application site (ca.10% of body surface) was moistered with arachis oil BP before application
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality twice daily; body weight on day 0 (before treatment), day 7 and 14, clinical observations(including irritation) daily (0.5, 1, 2 and 4 hours after dosing)
- Necropsy of survivors performed: yes
Statistics:
NA, limit test
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
very slight erythema, scabs and slight desquamation (glossy skin)
Body weight:
within expected ranges
Gross pathology:
no findings
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 is > 2000 mg/kg bw
Executive summary:

Groups of 5 rats/sex received a dermal application of 2000 mg/kg test substance during 24 hours under semi-occlusion. No effects other than slight irritation were found during the 14 day observation period. The dermal LD50 of the test substance is > 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Study with the test substance according to the guideline and under GLP. The LD50 is > 2000 mg/kg bw

Additional information

Acute toxicity via two routes of exposure was tested. An acute inhalation study is waived based on the low vapour pressure (2.3E-03 Pa at 25 °C) and the extreme viscosity of the test substance. Exposure via the inhalation route is expected to negligible.


Justification for selection of acute toxicity – oral endpoint
Study with the test substance according to the guideline and under GLP

Justification for selection of acute toxicity – dermal endpoint
Study with the test substance according to the guideline and under GLP.

Justification for classification or non-classification

No classification for acute toxicity is considered necessary.