Registration Dossier

Administrative data

Description of key information

The substance was concluded to be of no systemic toxicity after a single ingestion. The inhalation of a highly saturated vapour-aerosol-air-mixture represents an unlikely acute hazard.

Oral: LD50 > 8170 mg/kg bw (Sprague-Dawley rat, test comparable to OECD TG 401)

Inhalation: LC0 = approx. 0.23 mg/L (nominal) (rat, IRT comparable to OECD 403, adopted 1981)

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
study protocol is in principle similar to OECD TG 401, limited documentation
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
(adopted 1981)
Deviations:
yes
Remarks:
Observation period only 7 days instead of 14 days as outlined in OECD TG 401.
Principles of method if other than guideline:
Groups of Sprague-Dawley rats were treated by single gavage administration with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 7 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy. The LD50 value was estimated on the basis of the observed mortalities.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 230 g (mean), female: 182 g (mean)
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
emulsion in 0.5% aqueous CMC
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 35%
Doses:
10,000 µL/kg bw equivalent to approx. 8170 mg/kg bw (conversion in mg/kg bw is based on the density of 0.817 g/cm3).
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Frequency of weighing: days 0, 4, 7
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 8 170 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured.
Clinical signs:
No symptoms observed.
Body weight:
See details in remarks on results.
Gross pathology:
No abnormalities observed.

Table 1: Mean body weight (g) meisured in animals at three time points:

Dose (mg/kg bw) Gender day 0 day 4 day 7
8170 male 230.2 256.4 241
8170 femlae 182 187.2 200.4
Interpretation of results:
GHS criteria not met
Conclusions:
The application of the test substance by gavage up to a dose of 8170 mg/kg bw caused no systemic toxicity in rats.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
8 170 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
study protocol is in principle similar to OECD TG 403, limited documentation, no analytical monitoring of test atmosphere concentration
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
(adopted 1981)
Deviations:
yes
Remarks:
No analytical verification of test atmosphere concentration.
Principles of method if other than guideline:
The test demonstrates the toxicity of an atmosphere saturated with vapours of the volatile components of a test substance at the temperature chosen for vapour generation (20 °C). 6 rats per sex were exposed to the vapours or aerosol, generated by bubbling 200 L air/h through a substance column of about 5 cm above a fritted glassdisc in a glass cylinder for 8 h. The documentation of clinical signs was performed over a period of 8 days.
GLP compliance:
no
Test type:
other: Inhalation Risk Test (IRT)
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 217 g (mean), female: 176 g (mean)
Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
The test demonstrates the toxicity of an atmosphere saturated with vapours of the volatile components of a test substance at the temperature chosen for vapour generation (20 °C). 6 rats per sex were exposed to the vapours, generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glassdisc in a glass cylinder for 8 h.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
0.23 mg/L (nominal concentration based on the substance loss)
No. of animals per sex per dose:
6
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 8 days
- Frequency of observations: daily
- Frequency of weighing: day 0 and 8
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LC0
Effect level:
0.23 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
other: No mortality was observed when 12 rats were exposed for 8 hours to an atmosphere that had been saturated at 20°C with the volatile parts of the compound.
Mortality:
No mortality occured.
Clinical signs:
other: Slight irritation of mucous membranes.
Body weight:
The animals gained weight: males from 217 g to 244 g on day 8 (mean), and females from 176 g to 192 g (mean).
Gross pathology:
No abnormalities observed.

The test substance concentration was estimated to be approx. 0.23 mg/L at 20 °C. Vapour saturation was retrospectively calculated to be approx. 0.074 µg/L at 20 °C due to the low vapour pressure of the substance.

Interpretation of results:
GHS criteria not met
Conclusions:
No mortality was observed when 12 rats were exposed for 8 hours to an atmosphere that has been saturated at 20 degrees centigrade with the volatile components of the compound. The animals were exposed to a saturated vapour atmosphere.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
230 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral:

In an acute toxicity study conducted by BASF according to an internal protocol comparable to the OECD TG 401 groups of 5 Sprague-Dawley rats/sex/dose were administered a limit dose of 8170 mg/kg bw (emulsion in 0.5% aqueous CMC) by gavage and observed for 7 days for lethality and clinical signs of intoxication. No mortality, clinical signs and pathologic abnormalities were observed. Thus, the LD50 for oral acute toxicity in rats was estimated to be > 8170 mg/kg bw.

 

Inhalation:

Data on acute toxicity of the test material by the inhalation route are limited. There is an inhalation risk test available where in total six rats/sex were exposed for 8 hours to vapour-aerosol atmospheres saturated with the volatile parts of the substance at a nominal concentration of 0.23 mg/L. The animals were observed for a post-exposure period of 7 days for clinical signs of intoxication. No mortality occurred. Clinical signs were slight irritation of mucous membranes. No pathologic abnormalities were observed at necropsy.

Intraperitoneal:

Additional data on acute toxicity of the test material are available. In the intraperitoneal study groups of 5 NMRI mice/sex/dose were administered doses of 8170 or 3791 mg/kg bw (35% emulsion with 0.5% aqueous CMC). After interperitoneal application, mice were observed for 14 days. Mortality occurred in one male animal of the high dose group on day 7 after the start of substance administration. No abnormalities were observed in the animal at necropsy. The surviving 19 animals were sacrificed on day 14 and showed intraabdominal adhesions with fibrinous secretion of the serosa. Thus, a discriminating dose of 8170 mg/kg bw was set as effect level. Intraperitoneal injection is not considered as a relevant exposure route for humans for this substance.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008, as amended for the thirteenth time in Regulation (EU) No 2018/1480. As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008.