Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Oral:

In an acute oral toxicity study similar to OECD 401 guideline, a LD50 of above 5000 mg/kg bw was determined (BASF SE, 1980).

Dermal:
In an acute dermal toxicity study (limit test) according to OECD Guideline 402, a LD50 of above 2000 mg/kg was determined (BASF SE, 2016).

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:
1978-05-17 to 1980-03-26
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: Mean body weight: males 195 g, females 175 g
- Diet: The animals were offered a standardized animal laboratory diet.
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5 % aqueous CMC preparation
Details on oral exposure:
Test concentrations used: 21.5 and 50 %
Application volume: 10 mL/kg
Doses:
2150 and 5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
None.
Clinical signs:
other: Good general state.
Gross pathology:
Nothing abnormal detected.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: Young adult animals (male animals approx. 8 weeks, female animals approx. 12 weeks).
- Weight at study initiation: Animals of comparable weight.
- Housing: Single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Acclimatization period of at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 – 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5 %
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal and dorsolateral parts of the trunk.
- % coverage: About 40 cm² (corresponds to at least 10 % of the body surface)
- Type of wrap if used: semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: rinsing of the application site with warm water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 3.33 mL/kg bw
- Concentration: 60 g /100 mL
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs for each animal were recorded several times on the day of application and at least once during each workday thereafter. Individual body weights shortly before application (day 0), weekly thereafter and on the last day of observation. Individual readings 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), several times until the last day of observation. A check for any dead or moribund animals was made at least once each workday, these records are archived by Bioassay.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
not applicable
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
other: No systemic clinical signs were observed during clinical examination. Local effects males: Due to the black discoloration of the application area erythema could not be determined on study day 1 in four animals. In the fifth male animal erythema could not
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

Acute toxicity: via oral route
In a study similar to OECD 401 guideline, the acute oral toxicity of the test substance following a single oral administration in Sprague-Dawley rats was investigated (BASF SE, 1980). Two groups of 10 fasted animals (5 animals per sex and dose) were exposed to 2150 and 5000 mg/kg bw of unchanged test substance and observed for 14 days. No mortality occurred. Accordingly, the acute oral LD50 of the test substance after single oral administration to rats is > 5000 mg/kg bw.

Acute toxicity: via dermal route

In an acute dermal toxicity study (Limit Test) according to OECD Guideline 402 (BASF SE, 2016), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the test substance (as suspension in 0.5 % CMC-solution). The clipped application site (dorsal and dorso-lateral parts of the trunk, comprising at least 10 % of the total body surface) was covered by semi-occlusive dressing during the 24-hour exposure period. The animals were observed for 14 days.

- No mortality occurred

- No clinical signs were noted

- The following test item-related local effects were recorded during the course of the study, local effects occurred within 10 days after application:

- Very slight to moderate erythema (grade 1 to 3)

- Incrustations

- Marginal black discolored application area

- Due to the black discoloration of the application area erythema could not be determined on study day 1 in nine animals, while in one animal erythema could not be determined from study day 1 until study day 3.

- The body weight of the animals increased within the normal range throughout the study period with one exception. The body weight of one female animal nearly stagnated during the whole study period. As stagnation of body weight is generally known to occur as a consequence of the dermal application procedure, the body weight stagnation observed is considered to be unspecific.

- No macroscopic pathologic abnormalities were noted in all animals examined at the end of the study.

Accordingly, the acute dermal median lethal dose (LD50) in rat was determined to be above 2000 mg/kg bw.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the test item is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.