Registration Dossier

Administrative data

Description of key information

Two acute oral toxicity studies are available with the substance, conducted equivalent to OECD 401. The LD50 in mice was determined to be >5939 mg/kg and the LD50 in rats was determined to be approx. 7935 mg/kg. The lowest value is selected as the key value for the CSA.
An acute dermal toxicity study conducted with a substance analogue in accordance with OECD 402 and according to GLP principles was considered appropriate to determine the acute dermal toxicity of the substance. The acute dermal toxicity was determined to be >2612 mg/kg in a limit test.

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:
June 25, 1980 - August 4, 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study meets the EC Standards (conducted equivalent to OECD 401). Deviations: lack of study design details in the report, observation period of only 5 days, no body weight measurements, no clinical examinations and no necropsy carried out.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
lack of study design details in the report, observation period of only 5 days, no body weight measurements, no clinical examinations and no necropsy carried out
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
mouse
Strain:
CF-1
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: ca. 20 gram
No further details available
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No data available
Doses:
10, 15 and 20 mL/kg (aqueous solution)
No. of animals per sex per dose:
10 animals per dose (sex unknown)
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 5 days
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 15 - < 20 mL/kg bw
Based on:
test mat.
Remarks:
(aqueous solution)
Remarks on result:
other: Aqueous solution with a solid content of approximately 37%
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 16 050 - < 21 400 mg/kg bw
Based on:
test mat.
Remarks:
(aqueous solution)
Remarks on result:
other: Aqueous solution with a solid content of approximately 37%
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 939 - < 7 918 mg/kg bw
Based on:
other: expressed as solid content
Remarks on result:
other: Results expressed for the substance
Mortality:
- No mortalities occurred in the group administered 10 ml/kg.
- One and all ten animals died in the group of mice receiving 15 and 20 ml/kg bw, respectively
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data

RESULTS 

Group

Dose

(mL/kg b.w.)

Mortality

Group mortality

(%)

1

10.0

0/10

0

2

15.0

1/10

10

3

20.0

10/10

100

 

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study conducted equivalent to OECD 401, the LD50 was determined to be between 15 and 20 mL/kg (aqueous solution), which can be converted to between 16,050 and 21,400 mg/kg (for the aqueous solution). This corresponds to a LD50 between 5,939 and 7,918 mg/kg for the substance.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
5 939 mg/kg bw
Quality of whole database:
The study has Klimisch score 2

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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 236 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 612 mg/kg bw
Based on:
other: expressed as solid content
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
other: expressed as surfactant content
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 dermal ( rat): > 2612 mg/kg bw (expressed as solid content). This result is read across to the registered substance.
Executive summary:

An acute dermal toxicity study (limit test) was conducted with a related member of the chemical category (C8-C18 alkyl derivativies) in accordance with OECD 402 and according to GLP principles. A total of 10 rats (5 males and 5 females) were occlusive exposed to 4.47 mL/kg of an aqueous solution of the substance for 24 hours. The dose level was based on the surfactant content of the substance. One female was found dead on day 2. The majority of surviving animals showed chromodacryorrhoea, laboured respiration, rales, gasping, salivation, piloerection and hypothermia between days 1 and 2. No abnormalities were found at macroscopic post mortem examination of the surviving animals. Beginning autolysis was observed for the female that was found dead on day 2. Based on the results of this study the substance does not need to be classified for acute dermal toxicity in accordance with the CLP Regulation as the acute dermal toxicity of the substance was determined to be above 2612 mg/kg.

The results are read across to the registered substance.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 612 mg/kg bw
Quality of whole database:
The study (performed with substance analogue) has Klimisch score 1

Additional information

Acute toxicity: oral

There are two studies available, both performed similar to OECD 401. In both studies, the substance was studied as an aqueous solution. In an acute oral toxicity study in mice, the LD50 was determined to be between 15 and 20 mL/kg (aqueous solution), which corresponds to a LD50 in mice between 5939 and 7918 mg/kg for the substance. In an acute oral toxicity study in rats, the LD50 was determined to be 14.56 mL/kg (aqueous solution), which corresponds to a LD50 of approx. 7935 mg/kg for the substance. The lowest obtained dose descriptor (>5939 mg/kg) is selected as the key value for the chemical safety assessment.

Acute toxicity: dermal

An acute dermal toxicity study (limit test) was conducted with a substance analogue (C8-C18 alkyl derivativies) in accordance with OECD 402 and according to GLP principles. A total of 10 rats (5 males and 5 females) were occlusive exposed to 4.47 mL/kg of an aqueous solution of the substance for 24 hours. The dose level was based on the surfactant content of the substance. One female was found dead onday 2.The majority of surviving animals showed chromodacryorrhoea, laboured respiration, rales, gasping, salivation, piloerection and hypothermia between days 1 and 2. No abnormalities were found at macroscopic post mortem examination of the surviving animals. Beginning autolysis was observed for the female that was found dead on day 2. Based on the results of this study the acute dermal toxicity of the substance was determined to be above 2612 mg/kg.

The rationale to read across the data is attached in Section 13.

Justification for classification or non-classification

In accordance with the CLP Regulation the substance is not classified for acute toxicity as the LD50 oral in mice (and rats) was determined to be >5939 mg/kg and as the LD50 dermal in rats was determined to be >2612 mg/kg.