Registration Dossier

Administrative data

Description of key information

acute oral LD50 > 5000 mg/kg bw (OECD 425 limit test)

acute dermal LD50 > 2000 mg/kg bw (OECD 402 limit test); Each rat was symptom-free during the entire study. There was no evidence for an adverse effect.

acute inhalation toxicity: 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:
2016-03-22 till 2016-04-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The results of the study allow the calculation of the oral LD50 of the test item and permit the test item to be ranked according to most classification systems currently in use.
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Version / remarks:
2008
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
up-and-down procedure
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000, 5000 mg/kg bw
No. of animals per sex per dose:
2000 mg/kg: 1 female
5000 mg/kg: 3 female
Control animals:
no
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality was observed during the study.
Clinical signs:
All animals were symptom free during the entire study.
Body weight:
Body weight and body weight gain of the animals treated with AFLAMMIT PCO 962
showed no indication of a treatment-related effect.
Gross pathology:
No external or internal macroscopic findings were noted in study animals at necropsy on
Day 14.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the acute oral LD50 value of the test item
AFLAMMIT PCO 962 was found to be greater than 5000 mg/kg bw in female
Crl:WI rats.
The study result triggers the following classification/labelling:
- Regulation (EC) No 1272/2008 (CLP): none
- GHS (rev. 6) 2015: unclassified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

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:
2016-03-17 till 2016-03-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Type of coverage:
semiocclusive
Vehicle:
other: The test item was administered as a single dose without using any vehicle, but sufficient water was added to dampen the material to ensure good contact with the skin at the treatment.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortality occurred after a 24-hour dermal exposure of AFLAMMIT PCO 962
administered at 2000 mg/kg bw to Crl:WI male and female rats followed by a 14-day
observation period.
Clinical signs:
Each rat was symptom-free during the entire study.
Local sign was not noted in any of the study animals.
Body weight:
There were no effects on body weight or body weight gain during the observation
period.
Gross pathology:
No external or internal macroscopic findings were noted at a dose level of
2000 mg/kg bw at necropsy.
Interpretation of results:
GHS criteria not met
Conclusions:
The median lethal dose (LD50) of AFLAMMIT PCO 962 after a single dermal
administration was found to be greater than 2000 mg/kg bw in male and female
Crl:WI rats.
Each rat was symptom-free during the entire study. There was no evidence for adverse effcet.
The study result triggers no classification/labelling:
- Regulation (EC) No 1272/2008 (CLP): none
- GHS (rev. 6) 2015: Unclassified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification

Based on the available data, the substance is not classified for acute toxicity according to Regulation (EC) No 1272/2008.