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Diss Factsheets

Administrative data

Description of key information

The oral LD50 for the test substance was determined to be > 6500 mg/kg bw (reference 7.2.1 -1).

The dermal LD50 for the test substance was determined to be > 2000 mg/kg bw (reference 7.3.1-1).

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:
18 July 1969 - 27 October 1969
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Deviations:
yes
Remarks:
test item was tested as a 2-30% aqueous solution, observation period was 7 days
Principles of method if other than guideline:
- test item was tested as a 2-30% aqueous solution
- observation period: 7 days
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gassner/Ottobrunn
- Weight at study initiation: male: approx.165 g, female: approx. 150 g
- Diet: Altromin-"R" (Altromin GmbH, Lage/L.), ad libitum
- Water: ab libitum
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2%, 16% and 30%

MAXIMUM DOSE VOLUME APPLIED: 21.4 mL/kg bw
Doses:
200, 1600, 3200 and 6400 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: observations daily, weighing at the beginning of the study
- Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 500 mg/kg bw
Based on:
test mat.
Mortality:
In the highest dose group (6400 mg/kg bw) 3 of 10 female rats died 24 hours after administration of the test item. No further mortality was observed.
Clinical signs:
other: After application of the test item (6400 and 3200 mg/kg bw) prone position, apathy, dyspnoea and shaggy fur were observed. The rats showed no clinical signs after 4 and 7 days, respectively. No clinical signs were observed after application of 1600 and 20
Gross pathology:
no gross pathological findings
Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 for the test substance was determined to be > 6500 mg/kg bw.
Executive summary:

An acute oral toxicity study was performed with Sprague-Dawley rats. The test item was administered as 2-30% aqueous solution via gavage. Administered doses were 200, 1600, 3200 and 6400 mg/kg bw. The oral LD50 for the test substance was determined to be > 6500 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
discriminating dose
Value:
3 200 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:
5 November 1981 - 28 Dezember 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
yes
Remarks:
the observation period was 8 days
Principles of method if other than guideline:
observation period: 8 days
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
Vienna White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: GAUKLER, Offenbach
- Weight at study initiation: average weight: male: 2.97 kg, female: 3.14 kg
- Diet: Ovator-Solikanin 4 mm (Muskator-Werke, Düsseldorf) ad libitum
- Water: ab libitum

Type of coverage:
occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5%
Details on dermal exposure:
TEST SITE
- Area of exposure: average: male: 253 cm², female: 268 cm²
- Type of wrap if used: used but not specified

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water or a water-lutrol-mixture
- Time after start of exposure: 24 h

TEST MATERIAL
- Amounts applied: about 5-7 g
- Concentration: 2000 mg/kg (50% aquaeous suspension with 0,5% carboxymethylcellulose)
- Constant concentration used: yes

Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 8 days (killed on day 8)
- Frequency of observations: daily, on 3 study days
- Necropsy of survivors performed: yes
- Other examinations performed: clinicla signs, local irritation, histopathology
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
other: 1 male rabbit showed a minor apathy 50 minutes after substance application.
Gross pathology:
No substance induced findings.
Other findings:
24 hours after application minor skin irritation was observed. 6 days after application scaly skin was observed
Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 for the test substance was determined to be > 2000 mg/kg bw.
Executive summary:

An acute dermal toxicity study was performed with Vienna White rabbits. The test was performed as limit test at 2000 mg/kg bw with 5 male and 5 female animals. The test substance was applied to the shaved skin for 24 hours. The observation period was 8 days. No mortality was observed. The dermal LD50 for the test substance was determined to be > 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

Acute Toxicity: oral:

An acute oral toxicity study was performed with Sprague-Dawley rats. The test item was administered as 2-30 % aqueous solution via gavage. Administered doses were 200, 1600, 3200 and 6400 mg/kg bw. The oral LD50 for the test substance was determined to be > 6500 mg/kg bw (reference 7.2.1 -1). Furthermore, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS, reference 7.2.1 -2) gave a LD50 value of > 5100 mg/kg bw for both rats and mice. In dd mice the oral LD50 value for the test substance was determined to be 6332 mg/kg bw (Sado, reference 7.2.1 -3).

Acute Toxicity: dermal:

An acute dermal toxicity study was performed with Vienna White rabbits. The test was performed as limit test at 2000 mg/kg bw with 5 male and 5 female animals. The test substance was applied to the shaved skin for 24 hours. The observation period was 8 days. No mortality was observed. The dermal LD50 for the test substance was determined to be > 2000 mg/kg bw (Jäckh, reference 7.2.3 -1).

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available data are reliable and suitable for classification purposes under Regulation 1272/2008. Based on this data, the substance is considered not to be classified for acute oral and dermal toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EC) No 2017/776.