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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Acute oral LD50 in the rat 5200 mg/kg and dermal toxicity with LD0 of 8000 mg/kg.

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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Brief report of a study using a standard test method: no information on adverse reactions other than death, but sufficient to conclude an LD50 value.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Classical acute oral LD50 test using groups of 3 males, 2 females.
GLP compliance:
no
Remarks:
Pre-GLP study
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Sherman - Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Single oral dose after 24h starvation period.
Doses:
Volumes of 25% solution equivalent to 3.15, 4.0, 5.0, 6.25 and 7.9 g test substance/kg.
No. of animals per sex per dose:
3 males, 2 females.
Control animals:
no
Details on study design:
Animals observed for 14 days post-dose.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 200 mg/kg bw
Based on:
act. ingr.
95% CL:
>= 4 200 - <= 6 400
Remarks on result:
other: Dosages expressed in terms of active ingredient in the 25% solution tested.
Mortality:
All rats dosed at 7900 mg/kg died; no other deaths occurred.
Clinical signs:
other: No information given
Gross pathology:
Not evaluated
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An oral LD50 value of 5200 mg/kg was determined in this study.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
5 200 mg/kg bw
Quality of whole database:
Together the 4 studies provide sufficient evidence to come to a reliable conclusion.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
Low quality of available studies.

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Brief report of a study performed using a standard test method: contains sufficient information to conclude an LC0 value.
Qualifier:
according to guideline
Guideline:
other: US Federal Register 26 (1961) Section 191.10
GLP compliance:
no
Remarks:
Pre-GLP study
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
other: described as albino rabbits
Sex:
not specified
Details on test animals or test system and environmental conditions:
No further data available.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Dry powder test material moistened with saline and applied to clipped skin (intact for 2 rabbits/group, abraded to penetrate stratum corneum for 2 rabbits/group) under occlusive dressing.
Duration of exposure:
Up to 24h
Doses:
0.5, 1.5, 2.0, 4.0, 8.0 g/kg.
No. of animals per sex per dose:
2 rabbits, skin intact + 2 rabbits, skin abraded per dose. Sex not specified.
Control animals:
not required
Details on study design:
Animals observed for 14 days after dressing removal.
Sex:
not specified
Dose descriptor:
LD0
Effect level:
8 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths occurred.
Mortality:
No deaths occurred.
Clinical signs:
other: Not reported.
Gross pathology:
Not evaluated.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Application of test substance at up to 8000 mg/kg caused no deaths in this study, even when the possibilities for skin penetration were increased by abrasion of the test sites.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Value:
8 000 mg/kg bw
Quality of whole database:
The available studies (Klimisch 2) include sufficient information to conclude a reliable LC0 value.

Additional information

Low toxicity of the test substance following acute exposure by all three routes has been demonstrated in reliable studies

Justification for selection of acute toxicity – oral endpoint

Among 4 studies which together support a weight of evidence conclusion of low toxicity, the lowest defined LD50 value was that reported in the selected study: 5200 mg/kg.

Justification for selection of acute toxicity – inhalation endpoint

A rat 1h LC0 value of 5.5 mg/l (whole body exposure to a dust atmosphere) has been determined for the registered substance.  However, the short duration of the test and observation of increasing respiratory distress during the last 20 minutes of the test period make it impossible to extrapolate to a 4h LC50 value

Justification for selection of acute toxicity – dermal endpoint

No mortality occurred after dermal application of test substance to rabbits at up to 8000 mg/kg, even when the possibilities for skin penetration were increased by abrasion of test sites.

Justification for classification or non-classification

Acute toxicity via oral and dermal routes is low; while no 4h inhalation LC50 value is available, the1h inhalation LC0 value (>5.5 mg/l) suggests low acute toxicity by this route also. Accordingly, no classification in respect of acute toxicity is warranted.