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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Bächtold (1970): Under the conditions of this study the acute oral LD50 of the test material in mice was 13347 ± 1820 mg/kg bw.

Bächtold (1976): Under the conditions of this study the acute oral LD50 of the test material in rats was 12340 ± 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
Mice of both sexes were once treated by oral gavage and then observed for 10 days for time of death. 10 different batches of the test material were tested and 3 different doses were used: 6000, 12000 and 24000 mg/kg bw. Each dose was tested in 10 animals.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
mouse
Strain:
not specified
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
6000, 12000 and 24000 mg/kg bw
No. of animals per sex per dose:
10 animals per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 10 days
- Animals were observed for time of death
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
13 347 mg/kg bw
Based on:
test mat.
95% CL:
>= 11 527 - <= 15 167
Sex:
male/female
Dose descriptor:
other: LD10
Effect level:
9 136 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
other: LD90
Effect level:
19 670 mg/kg bw
Based on:
test mat.
Mortality:
All deaths occurred within 24 hours after dosing.
Interpretation of results:
other: Not classified in accordance with EU Criteria
Conclusions:
Under the conditions of this study the acute oral LD50 of the test material in mice was 13347 ± 1820 mg/kg bw.
Executive summary:

The acute oral toxicity of the test material to mice was investigated.

Mice of both sexes were once treated by oral gavage and then observed for 10 days for time of death. 10 different batches of the test material were tested and 3 different doses were used: 6000, 12000 and 24000 mg/kg bw. Each dose was tested in 10 animals. No further information on study design was available.

All deaths occurred within 24 hours after dosing. LD50 was calculated to be >10000 mg/kg bw. This was true for each batch tested.

Under the conditions of this study the acute oral LD50 of the test material in mice was 13347 ± 1820 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
10 rats per dose were treated once by oral gavage and the animals were observed for 10 days for time of death.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
not specified
No. of animals per sex per dose:
10 animals per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 10 days
- Animals were observed for 10 days for time of death.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
12 340 mg/kg bw
Based on:
test mat.
95% CL:
>= 10 340 - <= 14 340
Sex:
male/female
Dose descriptor:
other: LD10
Effect level:
7 870 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
other: LD90
Effect level:
19 400 mg/kg bw
Based on:
test mat.
Interpretation of results:
other:
Conclusions:
Under the conditions of this study the acute oral LD50 of the test material in rats was12340 ± 2000mg/kg bw.
Executive summary:

The acute oral toxicity of the test material to rats was investigated.

10 rats per dose were treated once by oral gavage and the animals were observed for 10 days for time of death. No further information available. The LD50 was calculated to be >10000 mg/kg bw.

Under the conditions of this study the acute oral LD50 of the test material in rats was12340 ± 2000mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
12 340 mg/kg bw
Quality of whole database:
Only little information is given about study procedures, however the available data is sufficient to show that the test material is of low acute oral toxicity.

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

Bächtold, mice (1970):

The acute oral toxicity of the test material to mice was investigated.

Mice of both sexes were once treated by oral gavage and then observed for 10 days for time of death. 10 different batches of the test material were tested and 3 different doses were used: 6000, 12000 and 24000 mg/kg bw. Each dose was tested in 10 animals. No further information on study design was available.

All deaths occurred within 24 hours after dosing. LD50 was calculated to be >10000 mg/kg bw. This was true for each batch tested.

Under the conditions of this study the acute oral LD50 of the test material in mice was 13347 ± 1820 mg/kg bw.

Bächtold, rats (1976):

The acute oral toxicity of the test material to rats was investigated.

10 rats per dose were treated once by oral gavage and the animals were observed for 10 days for time of death. No further information available. The LD50 was calculated to be > 10000 mg/kg bw.

Under the conditions of this study the acute oral LD50 of the test material in rats was 12340 ± 2000 mg/kg bw.

ACUTE INHALATION

In accordance with Column 2 of REACH, Annex VIII, information requirement 8.5.2 (acute toxicity by inhalation) testing is not appropriate as exposure of humans via inhalation is unlikely taking account of the operating conditions applied to substance manufacture and use and the risk manamegement measures that are applied. Furthermore, particle size distribution data indicates that the test material particles are too large to enter the airways (D10 = 23.64 µm; D50 = 50.11 µm, D90 = 90.01 µm) and are therefore not available to the airway to cause a toxic effect.

ACUTE DERMAL

In accordance with column 2 of REACH Annex VIII, information requirement 8.5.3 (acute toxicity by dermal route) testing is not considered to be appropriate because skin contact in production and/or use is unlikely. Furthermore, in vivo acute oral toxicity studies have revealed that the substance does not require classification for STOT-SE by the oral route, in vitro skin corrosion/irritation and skin sensitisation studies do not indicate effects following dermal exposure to the substance and no systemic toxicity is predicted.

Justification for classification or non-classification

Only little information is given about study procedures, however the available data is sufficient to show that the test material is of low acute oral toxicity. In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to acute oral toxicity.