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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 toxicity:
- rat (Wistar SPF) m/f; LD50 >10000 mg/kg bw [OECD TG 401, GLP]
- mouse (SuPH-Velaz) m/f; LD50 = 10000 mg/kg bw [OECD TG 401, GLP]
Acute inhalation toxicity:
- rat m/f; LC50 >0.005 mg/L air (≙ 5mg/m^3; 7h) [OECD TG 403, GLP]
Acute dermal toxicity:
- rat (Wistar) m/f; LD50 >5000 mg/kg bw (24h) [OECD guideline 402, GLP]

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:
other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
mouse
Strain:
other: SuPH-Velaz
Sex:
male/female
Route of administration:
oral: unspecified
Vehicle:
olive oil
Doses:
10000 mg/kg bw
No. of animals per sex per dose:
5
Sex:
male/female
Dose descriptor:
LD50
Effect level:
10 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: 10000 mg/kg bw, Number of animals: 5; Number of deaths: 0
Female: 10000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: No effects were observed.
Body weight:
No data
Gross pathology:
Effects on organs: Macroscopically no changes were observed.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
LD50 (mouse) = 10000 mg/kg bw
Executive summary:

The acute oral toxicity of the test substance has been determined in a GLP test with mice according to OECD Guideline No. 401. The LD50 value was 10000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
10 000 mg/kg bw
Quality of whole database:
The data has been extracted from ECHA databases. The files were first migrated from the SNIF (Structured Notification Interchange Format) format (used under Directive 67/548/EEC) into the IUCLID 5 format (used under the REACH Regulation) and represent all of the information that ECHA currently holds on this endpoint, which were submitted in the framework of a notification at least 12 years previously (as per Article 25(3)) for the substance with the same EC number for which you inquired.

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:
other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
Exposure duration: 7 hours
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
male/female
Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
other: for the product no aerodynamic diameter was used because the substance is a waxy solid.
Details on inhalation exposure:
7 hour exposure, whole body
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
7 h
Concentrations:
0.005 mg/L air ≙ 5 mg/m^3 air
No. of animals per sex per dose:
5
Control animals:
not specified
Sex:
male/female
Dose descriptor:
LC0
Effect level:
5 mg/m³ air
Based on:
test mat.
Remarks:
applicated concentration probably is the highest concentration which can be prepared (nearly saturated)
Exp. duration:
7 h
Remarks on result:
other: No deaths occurred at this concentration. LC50 > 5 mg/m3
Mortality:
Male: 5 mg/m^3 air; Number of animals: 5; Number of deaths: 0
Female: 5 mg/m^3 air; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: The appearance and the behaviour of the treated animals was not influenced during the 14 days observation period.
Body weight:
The body weight was not influenced.
Gross pathology:
No treatment related effects were observed in none of the organs of the animals which were treated with test substance. A decrease of the somatomotoric activities was observed in the control groups and in the test groups as well. This observation was related to the decreased temperature in the exposure chamber.

Exposure chambers were used.

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
LC50 (rat) > 5 mg/m^3 air (7h)
Executive summary:

The acute inhalation toxicity of the test substance has been determined in a GLP test with rats according to OECD Guideline No. 403. No deaths occurred at the highest dose tested, so the LC50 value is > 5 mg/m3 air (7h).

Endpoint conclusion
Dose descriptor:
discriminating conc.
Value:
5 mg/m³
Quality of whole database:
The data has been extracted from ECHA databases. The files were first migrated from the SNIF (Structured Notification Interchange Format) format (used under Directive 67/548/EEC) into the IUCLID 5 format (used under the REACH Regulation) and represent all of the information that ECHA currently holds on this endpoint, which were submitted in the framework of a notification at least 12 years previously (as per Article 25(3)) for the substance with the same EC number for which you inquired.

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: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Type of coverage:
semiocclusive
Vehicle:
olive oil
Duration of exposure:
24 h
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: 5000 mg/kg bw; Number of animals; 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: No effects.
Body weight:
No data
Gross pathology:
Effects on organs: No effects.
Other findings:
Signs of toxicity (local): No effects.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
LD50 > 5000 mg/kg bw
Executive summary:

The acute dermal toxicity of the test substance has been determined in a GLP test with rats according to OECD Guideline No. 402. The LD50 value was > 5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw
Quality of whole database:
The data has been extracted from ECHA databases. The files were first migrated from the SNIF (Structured Notification Interchange Format) format (used under Directive 67/548/EEC) into the IUCLID 5 format (used under the REACH Regulation) and represent all of the information that ECHA currently holds on this endpoint, which were submitted in the framework of a notification at least 12 years previously (as per Article 25(3)) for the substance with the same EC number for which you inquired.

Additional information

Acute oral toxicity:

The acute oral toxicity of the test substance has been determined in a GLP test with rats according to OECD Guideline No. 401. The LD50 value was > 10000 mg/kg bw. A similar result has been obtained in a GLP test with mice according to OECD Guideline No. 401. The LD50 value was 10000 mg/kg bw and the test subtstance does therefore not need to be classified according to Regulation 1272/2008/EC.

Acute inhalation toxicity:

The acute inhalation toxicity of the test substance has been determined in a GLP test with rats according to OECD Guideline No. 403. No deaths occurred at the highest dose tested, so the LC50 value is > 5 mg/m3air (7h) and the test subtstance does therefore not need to be classified according to Regulation 1272/2008/EC.

Acute dermal toxicity:

The acute dermal toxicity of the test substance has been determined in a GLP test with rats according to OECD Guideline No. 402. The LD50 value was > 5000 mg/kg bw and the test subtstance does therefore not need to be classified according to Regulation 1272/2008/EC.


Justification for selection of acute toxicity – oral endpoint
There are two equally reliable (GLP and guideline) studies available. Further, the results from both studies are almost identical, so the endpoint selection has no influence on the classification of the substance, as both lead to the conclusion that the test substance does not need to be classified.

Justification for selection of acute toxicity – inhalation endpoint
GLP and guideline study

Justification for selection of acute toxicity – dermal endpoint
GLP and guideline study

Justification for classification or non-classification

Acute oral toxicity:

The test material does not meet the criteria for classification and will not require labelling for oral toxicity in accordance with European Regulation (EC) No. 1272/2008.

Acute inhalation toxicity:

The test material does not meet the criteria for classification and will not require labelling for inhalation toxicity in accordance with European Regulation (EC) No. 1272/2008.

Acute dermal toxicity:

The test material does not meet the criteria for classification and will not require labelling for dermal toxicity in accordance with European Regulation (EC) No. 1272/2008.