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Diss Factsheets

Administrative data

Description of key information

The acute oral LD50 was calculated to be > 2000 mg/kg bw.

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:
2016-03-07 to 2016-04-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
December 17, 2001
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
30 May 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
Batch identification: 0013479406
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 10 weeks
- Weight at study initiation: 181 - 196 g
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: Single housing
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water: Tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 °C +/- 3 °C
- Humidity: 30-70 %
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0,5 %
Details on oral exposure:
VEHICLE
- Concentration of in vehicle: 20 g/100 mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: By request of the sponsor
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6: Only female animals (3 per test group)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred in both test groups.
Clinical signs:
other: In all animals of the first test group red discolored feces was observed from study day 1 until study day 2. In the second test group no clinical signs were observed.
Gross pathology:
There were no macroscopic pathological findings in all animals sacrificed at the end of the observation period.
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
Quality of whole database:
GLP and guideline compliant study

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity

Key study

In an acute oral toxicity study performed according to the acute toxic class method OECD 423 and GLP, 2000 mg/kg of the test item (preparations in 0.5% CMC-solution) were administered by gavage to two test groups of three fasted Wistar rats each (6 females).

The following test substance-related clinical observations were recorded. The observed clinical signs occurred within the first two days after administration:

2000 mg/kg (first test group): No mortality occurred, red discolored feces in all animals

2000 mg/kg (second test group): No mortality occurred, no clinical signs were observed.

The body weights increased within the normal range throughout the study period.

There were no macroscopic pathological findings at the end of the observation period.

The acute oral LD50 was calculated to be > 2000 mg/kg bw.

Supporting study

In a study according to EU method B.1, following the acute toxic class method, the test substance was administered to 3 male and 3 female Wistar rats at a single dose of 2000 mg/kg bw. The substance was applied by gavage as aquoeus solution. Animals were observed for a period of 14 days after application. On the first day, one male animal exhibited symptoms (impaired general state, dyspnoea, piloerection). No abnormalities were observed in the female animals. No deaths occurred. Therefore, the LD50 of the test substance was found to be greater than 2000 mg/kg bw.

As the test material was a preparation containing less than 20 % test substance, the available study was only considered as supporting information.

Acute inhalation toxicity

The study does not need to be conducted as the exposure route via inhalation is unlikely taking into account that no vapour pressure can be determined as the test substance decompose at > 200°C.

Acute dermal toxicity

The substance does not meet the criteria for classification as acutely toxic or STOT SE by the oral route, and no systemic effects have been observed in an in vivo skin sensitisation study with dermal exposure (LLNA; BASF report 58V0428/14X594 (2016)). Therefore, the acute dermal toxicity study is not required.

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. The acute oral LD50 was greater than 2000 mg/kg bw. As a result, the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.