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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

From a study with rats performed according to EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method) a LD50 value of > 2000 mg/kg bw was derived. There was no mortality and no other adverse effects were reported.

From a study with rats performed according to EU Method B.3 (Acute Toxicity (Dermal)) a LD50 value of > 2000 mg/kg bw was derived. There was no mortality and no other adverse effects were reported.

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:
1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
Identification: ELDEW PS-203
Description: pale yellow liquid
Batch: 808010
Expiry date: 31.03.2000
Purity: 100 %
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 8 – 10 weeks
- Weight at study initiation: 174 – 212 g
- Fasting period before study: ca. 17 h
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 40 – 70 %
- Photoperiod (hrs dark / hrs light): 12 / 12
Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
Application volume: 10 mL/kg bw
Doses:
2000 mg/kg
No. of animals per sex per dose:
3 m / 3 f
Control animals:
no
Details on study design:
Duration of observation period following administration: 14 days
Examinations: clinical signs and body weight
Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality in both sexes.
Clinical signs:
No clinical signs were observed during the study period.
Body weight:
The body weight of the animals was within the range commonly recorded for animals of this strain and age.
Gross pathology:
No adverse effects were noted.
Interpretation of results:
GHS criteria not met
Conclusions:
From a study with rats performed according to EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method) a LD50 value of > 2000 mg/kg bw was derived.
Executive summary:

From a study with rats performed according to EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method) a LD50 value of > 2000 mg/kg bw was derived.

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:
1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes
Specific details on test material used for the study:
Identification: ELDEW PS-203
Description: pale yellow liquid
Batch: 808010
Expiry date: 31.03.2000
Purity: 100 %
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9 - 12 weeks
- Weight at study initiation: 200 - 234 g
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 40 – 70 %
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
About 24 h before treatment the backs of the animals were clipped exposing an area of ca. 10 % of the total body surface. On test day 1 the test item was applied at a dose level of 2000 mg/kg bw evenly on the intact skin. The application volume was 2.16 mL/kg bw. 24 h after treatment the dressing was removed and the skin was flushed with water and dried with paper towels.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 m / 5 f
Control animals:
no
Details on study design:
Duration of observation period following administration: 14 days
Examinations: clinical signs and body weight
Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
No mortality in both sexes.
Clinical signs:
No clinical signs were observed during the study period.
Body weight:
The body weight of the animals was within the range commonly recorded for animals of this strain and age.
Gross pathology:
No adverse effects were noted.
Interpretation of results:
GHS criteria not met
Conclusions:
From a study with rats performed according to EU Method B.3 (Acute Toxicity (Dermal)) a LD50 value of > 2000 mg/kg bw was derived.
Executive summary:

From a study with rats performed according to EU Method B.3 (Acute Toxicity (Dermal)) a LD50 value of > 2000 mg/kg bw was derived.

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

From a study with rats performed according to EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method) a LD50 value of > 2000 mg/kg bw was derived. There was no mortality and no other adverse effects were reported.

From a study with rats performed according to EU Method B.3 (Acute Toxicity (Dermal)) a LD50 value of > 2000 mg/kg bw was derived. There was no mortality and no other adverse effects were reported.

Therefore, there is no need to classify the test item according to CLP.