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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Oral Toxicity


The test substance was assessed in healthy random bred rats of the Tif RAif (SPF) strain. The animals were tested for acute oral toxicity. Animals were fasted overnight and treated by oral intubation. Physical condition and rate of deaths were monitored throughout the whole observation period. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. Additionally in the highest dosage group convulsions and trismus were also observed. The surviving animals recovered within 7 to 12 days. The acute oral LD50 of the test material in rats of both sexes observed over a period of 14 days was demonstrated to be 3398 (2812-4108) mg/kg bw.


 


Dermal Toxicity


The acute dermal toxicity in rats of both sexes was assessed. Healthy random bred rats of the Tif: RAif (SPF) strain were prepared for testing approximately 24 hours before treatment by shaving an area on the back of the rats of approximately 60 square cm with an electric clipper. The test material was evenly dispersed on the skin with a syringe and was covered with an occlusive dressing which was fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed, the skin was cleaned with lukewarm water and the reaction of the skin was appraised. No symptoms and no local skin irritation were seen. No mortalities occurred; no substance related gross organ changes were seen. The acute dermal LD50 of the test material in rats of both sexes observed over a period of 14 days is greater than 3170 mg/kg bw.



Inhalation Toxicity
In accordance with column 2 of REACH (Regulation (EC) No 1907/2006) Annex VIII, the acute toxicity by inhalation study (required in section 8.5.2) does not need to be conducted as acute toxicity studies are available for the oral and dermal routes of exposure. Furthermore, the substance is marketed as a
component of a product which is made of a vicous liquid, which is not inhalable

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
Study period:
study report 29- OCT-1976 - no additional details
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
prior to GLP
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Tif RAIf (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
Healthy random bred rats of the Tif RAif (SPF) strain raised on our premises were used for these experiments.
They were kept at a room temperature of 22 +/- 1° C, at a relative humidity of 55 +/- 5 % and on a 14 hours light cycle day. They received ad libitum rat food - NAFAG, Gossau SG - and water. Prior to treatment the animals were adapted for a minimum of 4 days and the initial body weight ranged from 160 to 180 grams.
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
2%
Details on oral exposure:
Animals fasted overnight were treated by oral intubation.
Doses:
775, 1000, 2150, 3170, 4640, 7750 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages (type 3) .
Animals fasted overnight were treated by oral intubation. Physical condition and rate of deaths were monitored throughout the whole observation
period.
Statistics:
LD 50 including 95 % confidence limits were calculated by the probit analysis method (Goulden A., Methods of Statistical Analysis, John Wiley and Sons, 1960, 3rd printing, pages 404-408).
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 398 mg/kg bw
Based on:
test mat.
95% CL:
2 812 - 4 108
Mortality:
5 males and 5 females per dose group
1 hour: no deaths

24 hours: no deaths at 775 and 1000 mg/kg; 1 female at 2150 mg/kg; 2 males and 3 females at 3170 mg/kg; 2 males and 3 females at 4640 mg/kg; 5 males and 5 females at 7750 mg/kg

48 hours: no deaths at 775 and 1000 mg/kg ; 1 female at 2150 mg/kg; 2 males and 3 females at 3170 mg/kg; 2 males and 4 females at 4640 mg/kg; 5 males and 5 females at 7750 mg/kg

7 and 14 days: no deaths at 775 and 1000 mg/kg ; 1 female at 2150 mg/kg; 2 males and 3 females at 3170 mg/kg; 3 males and 4 females at 4640 mg/kg; 5 males and 5 females at 7750 mg/kg
Clinical signs:
other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. Additionally in the highest dosage group convulsions and trismus were also observed. The surviving animals recovered wit
Gross pathology:
They were submitted to a necropsy whenever they died, survivors at the end of the observation period. No substance related gross organ changes were seen.
Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The acute oral LD50 of the test material in rats of both sexes observed over a period of 14 days is 3398 (2812-4108) mg/kg*.
Executive summary:

Healthy random bred rats of the Tif RAif (SPF) strain were tested for acute oral toxicty of the test material..

Animals were fasted overnight and treated by oral intubation. Physical condition and rate of deaths were monitored throughout the whole observation period. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. Additionally in the highest dosage group convulsions and trismus were also observed. The surviving animals recovered within 7 to 12 days.

The acute oral LD50 of the test material in rats of both sexes observed over a period of 14 days was demonstrated to be 3398 (2812-4108) mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 398 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
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
study report 26 Oct 1976 (no additional details)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
3 animals per sex per dose; two doses
GLP compliance:
no
Remarks:
prior to GLP
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Tif: RAif (SPF) strain
Sex:
male/female
Details on test animals or test system and environmental conditions:
Healthy random bred rats of the Tif: RAif (SPF) strain raised on our premises were used for these experiments.
They were kept at a room temperature of 22 + 1° C, at a relative humidity of 55 + 5 % and on a 14 hours light cycle day. They received ad libitum rat food - NAFAG, Gossau SG - and water. Prior to treatment the animals were adapted to our laboratories for a minimum of 4 days and the initial body weight ranged from 180 to 200 grams.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
During the treatment and observation period the rats were housed individually in Macrolon cages (type 2). Approximately 24 hours before treatment an area on the back of the rats of approximately 60 square em was shaved with an electric clipper.
For treatment the test material was evenly dispersed on the skin with a syringe and was covered with an occlusive dressing which was fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed, the skin was cleaned with lukewarm water and the reaction of the skin was appraised.
Duration of exposure:
24 hours
Doses:
2150 and 3170 mg/kg (No higher doses were possible)
No. of animals per sex per dose:
3
Control animals:
not required
Details on study design:
Three anmals per sex per dose group. During the treatment and observation period the rats were housed individually in Macrolon cages. Approximately 24 hours before treatment an area on the back of the rats of approximately 60 square cm was shaved with an electric clipper. For treatment the test material was evenly dispersed on the skin with a syringe and was covered with an occlusive dressing which was fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed, the skin was cleaned with lukewarm water and the reaction of the skin was appraised.
Statistics:
not applicable
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 170 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality
Mortality:
no mortalitily in any dose group
Clinical signs:
other: No symptoms and no local skin irritation were seen.
Gross pathology:
No substance related gross organ changes were seen.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 of the test material in rats of both sexes observed over a period of 14 days is greater than 3170 mg/kg .
Executive summary:

Healthy random bred rats of the Tif: RAif (SPF) strain were prepared for testing approximately 24 hours before treatment by shaving an area on the back of the rats of approximately 60 square cm with an electric clipper. The test material was evenly dispersed on the skin with a syringe and was covered with an occlusive dressing which was fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed, the skin was cleaned with lukewarm water and the reaction of the skin was appraised.

No symptoms and no local skin irritation were seen. No mortalities occurred; no substance related gross organ changes were seen.

The acute dermal LD50 of the test material in rats of both sexes observed over a period of 14 days is greater than 3170 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 170 mg/kg bw

Additional information

Justification for classification or non-classification

The acute oral and dermal LD50 values for rats were 3398 and >3179 mg/kg bw respectively, thereby identifiying low acute toxicity.