Registration Dossier

Administrative data

Description of key information

Acute oral toxicity in rats (comparable to OECD 401)

Acute dermal toxicity in rats (OECD 402)

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:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes
Specific details on test material used for the study:
TEST MATERIAL NAME (as stated in study report): TK 12437

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor; Batch No. 678
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
not specified
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
not specified
Doses:
2000 mg/kg
No. of animals per sex per dose:
three males and three females
Control animals:
no
Details on study design:
- Duration of observation period following administration: at least 10 days
- Observation for signs and symptoms: yes
- Necropsy of survivors performed: yes
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study
Clinical signs:
Ruffled für, dyspnea, and hunched posture were seen. Animals recovered within 10 days.
Gross pathology:
At autopsy, no deviations from normal morphology were found.
Interpretation of results:
GHS criteria not met
Remarks:
Not classified by CLP Criteria
Conclusions:
In an exploratory study, the acute oral LD50 of TK 12437 in rats was > 2,000 mg/kg. No mortality occurred during the study.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 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:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
February 24, 1987
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes
Specific details on test material used for the study:
TEST MATERIAL NAME (as stated in study report): TK 12437 (Trade Name: Irgastab CH 302)

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor; Batch No. 08520495
- Expiration date of the lot/batch: July, 1996
- Purity: within the product specifications

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Species:
rat
Strain:
other: Tif: RAI f (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: in house
- Age at study initiation: young adult
- Weight at study initiation: 209 to 247 g
- Housing: individually in Macrolon cages type 3, with standardized soft wood bedding
- Diet (e.g. ad libitum): Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland); ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 55 + 10 %
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Approximately 24 hours before treatment an area on the back of the rat of at least 10% of the body surface was shaved with an electric clipper.

The test article was evenly dispersed on the skin. It was covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed and the skin was cleaned with lukewarm water. Thereafter the skin reaction was appraised repeatedly,
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed for mortality daily, a.m. and p.m. on working days, a.m. on weekend days. Observed for signs and symptoms daily.
- Body weights: immediately before application and on days 7 and 14.
- Necropsy of survivors performed: yes
Statistics:
Not needed
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities occurred in this study.
Clinical signs:
Piloerection was observed in males and females on the day of application. At the application site, erythema was observed in the females followed by slight necrosis.
Females recovered within 14 days.
Body weight:
All animals gained weight throughout the study.
Gross pathology:
No deviations from normal morphology were found.
Interpretation of results:
GHS criteria not met
Remarks:
Not classified by CLP criteria
Conclusions:
In a guideline (OECD 402) rat study, the acute dermal LD50 of Irgastab CH 302 was > 2,000 mg/kg. No mortality occurred during the study.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

In an exploratory study, the acute oral LD50 of Irgastab CH 302 in rats was > 2,000 mg/kg.

In a guideline (OECD 402) rat study, the acute dermal LD50 of Irgastab CH 302 was > 2,000 mg/kg.

No mortality occurred during these studies.

Justification for classification or non-classification

Based on the availble data, Irgastab CH 302 is not classified for acute oral or acute dermal toxicity according to Regulation (EC) No 1272/2008.