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Description of key information

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 May to 10 June 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study undertaken at GLP accredited laboratory to internationally accepted guidelines.
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
other: CD(Crl:CD(SD)IGS BR)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Commercial laboratory rat supplier
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: Yes
- Housing: The animals were housed in groups of three in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: Certified Rat and Mouse Diet (Code 5LF2) supplied by International Product Supplies Limited, Wellingborough, Northants, UK was allowed throughout the study
- Water: ad libitum
- Acclimation period: at least 5 days

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

Route of administration:
oral: gavage
Vehicle:
DMSO
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/ml

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the absence of data suggesting the test material was toxic, 2000 mg/kg was chosen as the
starting dose.
Doses:
One dose of 2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 1/2 hour, 1 hour, 2 hours, 4 hours and once daily for 14 days
- Frequency of observations and weighing: Prior to dosing and at 7 and fourteen days
- Necropsy of survivors performed: yes
- Other examinations performed: All animals were subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs.
Preliminary study:
No preliminary study.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Female: 2000 mg/kg bw; Number of animals: 6; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
There were no deaths or signs of systemic toxiity.

All animals showed expected gains in bodyweight over the
study period.
Gross pathology:
Effects on organs:
No abnormalities were noted at necropsy.
Other findings:
- Other observations: No abnormalities detected
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated as being greater than 2500 mg/kg bodyweight.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Klimisch 1

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 June to 01 July 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study undertaken at GLP accredited laboratory to internationally accepted guidelines.
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:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
other: Sprague-Dawley CD (Cd: CD® (SD) IGS BR)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Commercial laboratory animal supplier.
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: >= 200g
- Fasting period before study: No
- Housing: The animals were housed in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: Free access to food (Certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Limited, London, UK) was allowed throughout the study.
- Water: Free access to mains drinking water was allowed throughout the study.
- Acclimation period: >= 5 days

ENVIRONMENTAL CONDITIONS
- Temperature): 19 to 25°C
- Humidity: 30 to 70%
- Air changes: The rate of air exchange was at least fifteen changes per hour
- Photoperiod: The lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

Type of coverage:
semiocclusive
Vehicle:
arachis oil
Details on dermal exposure:
TEST SITE
- Area of exposure:
- % coverage: 10
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated skin and surrounding hair wiped with cotton wool moistened with arachis oil BP to remove any residual
test material.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied 10 ml/kg
- Concentration: 200 mg/ml
- For solids, paste formed: no

VEHICLE
- Amount applied: No data

Duration of exposure:
24 h
Doses:
One
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 1/2 hour, 1 hour, 2 hours, 4 hours and 14 days
- Frequency of observations and weighing: At 0, 7 and 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,rgan weights, histopathology. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities.
Preliminary study:
No study undertaken
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: There were no signs of systemic toxicity throughout the study.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
Effects on organs: No abnormalities were noted at macroscopic examination at study termination.
Other findings:
Signs of toxicity (local): There were no deaths and no clinical signs of dermal irritation.

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dennal median lethal dose (LD50) ofthe test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mgIkg bodyweight.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Klimisch 1

Additional information

Justification for selection of acute toxicity – oral endpoint

The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated as being greater than 2500 mg/kg bodyweight.

Justification for selection of acute toxicity – inhalation endpoint

The use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and no acute inhalation test was performed.

Justification for selection of acute toxicity – dermal endpoint

The acute dermal median lethal dose (LD50) ofthe test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mgIkg bodyweight.

Justification for classification or non-classification

The studies for acute toxicity via the oral and dermal routes were found not to return results requiring classification. Therefore BPS-MAE is not classified for acute toxicity.