Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Acute toxicity is discussed.

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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study not conducted in compliance with GLP and test standard not referenced within the report, however data included for OECD SIDS dossier data. Read across to supporting substance, CAS No. 68442-68-2, by structural analogue.
Justification for type of information:
Please refer to IUCLID Section 13 for the read-across justification.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: Not specified
Principles of method if other than guideline:
Method not specified; however given the age of the study, a standard acute method is most appropriate.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
Not specified
Route of administration:
oral: unspecified
Vehicle:
corn oil
Remarks:
25%
Details on oral exposure:
The material was placed in a 25% corn oil solution.
Doses:
2500, 5000, 10000, 20000, and 40000 mg/kg
No. of animals per sex per dose:
Five rats per dose.
Control animals:
no
Details on study design:
The animals were observed for 14 days.
Statistics:
Not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Based on:
not specified
Mortality:
Two of the five animals died at the dosages of 20000 and 40000 mg/kg.
Clinical signs:
other: No data
Gross pathology:
No data
Other findings:
Not specified
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 > 20000 mg/kg bw
Executive summary:

Study not conducted in compliance with GLP and test standard not referenced within the report, however data included for OECD SIDS dossier. LD50 > 20000 mg/kg bw. Read across to supporting substance, CAS No. 68442 -68 -2, by structural analogue.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
Not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study not conducted in compliance with GLP and testing standard not specified within the report, however data is included for the OECD SIDS dossier. Read across to supporting substance, CAS No. 68608-77-5, by structural analogue.
Justification for type of information:
Please refer to IUCLID Section 13 for the read-across justification.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: Not specified
GLP compliance:
no
Test type:
other: Not specified
Species:
rat
Strain:
other: Charles River strain (COBS)
Sex:
male/female
Details on test animals or test system and environmental conditions:
Not specified
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Not specified
Doses:
10,250, 15,380, 23,070, or 34,600 mg/kg
No. of animals per sex per dose:
2/sex/group
Control animals:
no
Details on study design:
Animals were observed for toxic signs; body weights were recorded at the beginning of the study and at the end of the 14-day observation period.
Statistics:
Not specified
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 34 600 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed at any of the doses.
Clinical signs:
other: No data recorded
Gross pathology:
No data recorded
Other findings:
No data recorded
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 > 34,600 mg/kg bw
Executive summary:

Study not conducted in compliance with GLP and testing standard not specified within the report, however data included in the OECD SIDS dossier data. Read across to supporting substance, CAS No. 68608 -77 -5, by structural analogue.

LD50 > 34,600 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
20 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study not conducted to GLP and test standard not referenced within the report, however data included for OECD SIDS dosser. Read across to supporting substance, CAS No. 68442-68-2, by structural analogue.
Justification for type of information:
Please refer to IUCLID Section 13 for the read-across justification.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: Not specified
Principles of method if other than guideline:
Method not specified; however given the age of the study, a standard acute method is most appropriate.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
Not specified
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
Not specified
Duration of exposure:
Not specified
Doses:
Not specified
No. of animals per sex per dose:
5 animals used in total
Control animals:
not specified
Details on study design:
Not specified
Statistics:
Not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
not specified
Mortality:
No animals died after administration of 10000 mg/kg
Clinical signs:
other: No data
Gross pathology:
No data
Other findings:
Not specified
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 > 10000 gm/kg bw
Executive summary:

Study not conducted in compliance with GLP and test standard not referenced within the report, however data included for OECD SIDS dossier. LD50 > 10000 mg/kg bw. Read across to supporting substance, CAS No. 68442 -68 -2, by structral analogue.

Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study not conducted in compliance with GLP and test standard not specified in the report, however data is included for the OECD SIDS Dossier. Read across to supporting substance, CAS No. 68608-77-5, by structural analogue.
Justification for type of information:
Please refer to IUCLID Section 13 for the read-across justification.
Reason / purpose for cross-reference:
read-across source
Qualifier:
no guideline available
Principles of method if other than guideline:
Method not specified; however given the age of the study, a standard acute method is most appropriate.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
other: New Zealand White
Sex:
not specified
Details on test animals or test system and environmental conditions:
Not specified
Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
The test material was applied to a shaved area on the backs of four rabbits and then covered with an impervious plastic sheeting.
Duration of exposure:
4 hours
Doses:
Not specified
No. of animals per sex per dose:
Four animals
Control animals:
no
Details on study design:
After 4 hours the test material was removed, and the sites were examined for local reactions. Animals were observed for toxic signs; body weights were recorded at the beginning of the study and at the end of the 14-day observation period.
Statistics:
Not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Based on:
not specified
Mortality:
No mortality was observed at any of the doses.
Clinical signs:
other: Skin reactions were limited to mild erythema, desquamation, and edema. Only barely perceptible to slight erythema and desquamation were present at day 14.
Gross pathology:
Not specified
Other findings:
Not specified
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 > 3000 mg/kg bw (LD50 not specified within the study report, but assumed to be LD50 based on the effects noted).
Executive summary:

Study not conducted in compliance with GLP and test standard not specified within the study report, however data included for the OECD SIDS dossier. Result: > 3000 mg/kg bw ( LD50 not specified within the study report, but assumed to be LD50 based on the effects noted). Read across to supporting substance, CAS No. 68608 -77 -5, by structural analogue.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 000 mg/kg bw

Additional information

The substance, by use of read across to suitable analogues, is not considered to be acutely harmful via oral or dermal exposure. Historical dose levels are sufficiently high to draw this conclusion.


Justification for selection of acute toxicity – oral endpoint
Two results are available for read across purposes from equivalent substances. Both results indicate that this category of substances are not acutely harmful by oral ingestion. For the purposes of hazard assessment, the lower of the available LD50's is utilised as a worst case assessment.

Justification for selection of acute toxicity – inhalation endpoint
No data available. The substance is of low volatility, and is not utilised in exercises where aerosols could be generated. As a result, inhalation is not considered to be a primary route of exposure.

Justification for selection of acute toxicity – dermal endpoint
Two results are available for read across purposes from equivalent substances. Both results indicate that this category of substances are not acutely harmful by dermal exposure. For the purposes of hazard assessment, the lower of the available LD50's is utilised as a worst case assessment.

Justification for classification or non-classification

The above studies have all been ranked reliability 2 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were not conducted to GLP but are in compliance with agreed "older" protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

The above results triggered no classification under the CLP Regulation (EC No 1272/2008). No classification for acute effects is therefore required.