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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

In a reliable acute toxicity study the substance was administered to Sprague Dawley rats (5 animals/sex/dose) by oral gavage at a dose level of 2000 mg/kg bw (single administration). The oral LD50 is >2000 mg/kg bw. In a second reliable acute oral toxicity study the substance was administered to rats (5 animals/sex/dose) by oral gavage at a dose level of 10000 mg/kg bw (single administration). The LD50 is 10000 mg/kg bw.

In a reliable acute toxicity study a structurally similar substance was administered to Sprague Dawley rats (6 animals) by oral gavage at a dose level of 2000 mg/kg bw (single administration). The oral LD50 is >2500 mg/kg bw.

In a reliable acute toxicity study a structurally similar substance was administered to Sprague Dawley rats (5 animals/sex) by semi-occluded dermal application for 24 hours at a dose level of 2000 mg/kg bw (single administration). The dermal LD50 is >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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Read-across to K1 study therefore K2 is the maximum Klimisch value.
Justification for type of information:
Read-across approach - see read-across justification in section 13.
Reason / purpose for cross-reference:
read-across source
GLP compliance:
yes
Test type:
acute toxic class method
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Mortality:
No deaths
Clinical signs:
other: No signs of systemic toxicity
Gross pathology:
No abnormalities were noted at necropsy
Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 for the substance was > 2500 mg/kg (2000 mg/kg).
Executive summary:

In an acute toxicity study the substance was administered to Sprague Dawley rats (6 animals) by oral gavage at a dose level of 2000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was comparable with the control animals and no abnormalities found at macroscopic post-mortem examination. The LD50 is >2500 mg/kg bw as concluded by the study facilitator.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 March 1998 - 21 April 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
24 February 1997
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Five/sex
Control animals:
no
Preliminary study:
One male and one female rat was administered the substance via oral gavage at a dose of 2000 mg/kg bw. There were no clinical toxicity or mortality. Based on this inforamtion a dose of 2000 mg/kg bw was chosen for the main study.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One female was found dead two days after dosing.
Clinical signs:
other: No signs of systemic toxicity (except for the dead female) was observed.
Gross pathology:
Abnormalities noted at necropsy of the dead female included haemorrhagic lungs, dark liver, pale spleen, dark kidneys, pale gastric mucosa and gaseous distension of the stomach and large intestines. No abnormalities were noted of the animals terminated at the end of the study.
Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 is >2000 mg/kg bw.
Executive summary:

In an acute toxicity study the substance was administered to Sprague Dawley rats (5 animals/sex/dose) by oral gavage at a dose level of 2000 mg/kg bw (single administration). One female was found dead two days after dosing. Abnormalities noted at necropsy of the dead female included haemorrhagic lungs, dark liver, pale spleen, dark kidneys, pale gastric mucosa and gaseous distension of the stomach and large intestines. This was attributed to misadministration. No abnormalities were noted of the other animals terminated at the end of the study. There were no other signs of clinical toxicity, mean body weight gain was as expected. The oral LD50 is >2000 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07 October 1986 - 21 October 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
May 12th, 1981
Deviations:
not specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: boron: HISW (SPF TNO)
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
10000 mg/kg bw
No. of animals per sex per dose:
5 animals/sex/dose
Control animals:
no
Preliminary study:
A preliminary study was conducted but the details of this were not included in the study report.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities.
Clinical signs:
other: One after administration, the animals displayed slightly rough coat, later also slight squatting, and 3 animals had diarrhea. After 24 hours, all animals were free from symptoms of intoxication.
Gross pathology:
No abnormalities found at macroscopic post-mortem examination.
Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 is 10000 mg/kg bw.
Executive summary:

In an acute oral toxicity study the substance was administered to rats (5 animals/sex/dose) by oral gavage at a dose level of 10000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was as expected and no abnormalities were found at macroscopic post-mortem examination. The LD50 is 10000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Sufficient to address requirements.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Read-across to K1 study therefore K2 is the maximum Klimisch value.
Justification for type of information:
Read-across approach - see read-across justification in section 13.
Reason / purpose for cross-reference:
read-across source
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hour
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex
Control animals:
no
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No Mortality
Clinical signs:
other: No systemic toxicity observed
Gross pathology:
No abnormalities were reported at necropsy.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 of the substance was found to be > 2000 mg/kg body weight.
Executive summary:

In an acute toxicity study the substance was administered to Sprague Dawley rats (5 animals/sex) by semi-occluded dermal application for 24 hours at a dose level of 2000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was comparable with the control animals and no abnormalities found at macroscopic post-mortem examination. The LD50 is >2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Sufficient to address requirements.

Additional information

Justification for classification or non-classification

Based on the findings of reliable oral and dermal toxicity study conducted on the substance, classification of the substance is not justified.