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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

An acute oral toxicity study is available. A waiver is proposed for acute inhalation toxicity based on the physiochemical properties of the substance. A waiver is proposed for acute dermal toxicity based on the low acute toxicity of the substance.

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:
25 May 1995 to 31 Jul 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
not specified
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes
Specific details on test material used for the study:
Betadet S-20
Lot number: 7244
Appearance: transparent viscous liquid
pH: 7.49
Stored: Room temperature, protected from light.
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Eleven Wistar rats Crl (WI)BR (5 males and 6 females) were used. Females were nulliparous and non-pregnant.
Weight on receipt: 80-95 g
Age on receipt: approximately 4 weeks
Source: Charles River
Housing: Makrolon cages with sawdust bedding; Up to five animals of same sex per cage
Acclimatisation period: at least five days
Weight at dosing: 111 g (preliminary experiment) 108-124 g (main study)
Temperature: 19-26 degrees C
Humidity: 32-86%
Photoperiod: 12 dark/light cycle
Diet: Standard rat diet UAR A04C, supplied by Usine d’Alimentation Rationnelle, ad libitum
Water: Supplied by Compañia de Aguas de Sabadell, ad libitum
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Test substance administered orally by gastric intubation using metal catheter.
Test substance diluted in bidistilled water immediately before administration.
Single dose at volume of 10 mL/kg bw.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
1 female (preliminary experiment)
5/sex (main experiment)
Control animals:
no
Details on study design:
One female dosed in preliminary experiment. Rat observed twice daily for 7 days.

One group dosed in main experiment which comprised 5 males and 5 females. Rats observed twice daily for 14 days.

Observations included changes in skin and fur, changes in skin and fur, eyes and mucous membranes, respiratory, circulatory, central and autonomous nervous systems, somatomotor activity and behaviour patterns.

Rats were weighed before administration, daily for the first three days and then weekly. Animals were also weighed before being sacrificed.

All animals were sacrificed by carbon dioxide inhalation and subjected to necropsy.
Statistics:
None
Preliminary study:
No mortality.
Slightly soft faeces observed in the course of the following day post-treatment.
No clinical signs for remaining observation period.
Normal evolution of body weight.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other:
Remarks:
No mortality at the limit dose
Mortality:
No animals died during the study.
Clinical signs:
other: All animals showed slightly soft faeces in the course of the following day post-treatment. No clinical signs for remaining observation period.
Gross pathology:
No visible macroscopic lesions related to treatment.

No deaths occurred at the limit dose of 2000 mg/kg bw.

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
No deaths occurred at the limit dose of 2000 mg/kg bw.
Executive summary:

Betadet S-20 was tested for acute oral toxicity in the rat following oral administration. The study followed EC guideline Part B, Method B1 bis. (29 Dec 1992). Slightly soft faeces were observed on the day following administration. There were no other clinical observations. No mortalities, changes in body weight or gross pathology changes were noted. Betadet S-20 is considered to be free of any significant toxicity and does not require classification according to the CLP Regulation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Study is GLP compliant and reliable without restrictions.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity

Betadet S-20 was tested for acute oral toxicity in the rat following oral administration. The study followed EC guideline Part B, Method B1 bis. (29 Dec 1992). Slightly soft faeces were observed on the day following administration. There were no other clinical observations. No mortalities, changes in body weight or gross pathology changes were noted. Betadet S-20 is considered to be free of any significant toxicity and does not require classification according to the CLP Regulation.

Acute inhalation toxicity

A waiver is proposed based on the physicochemical properties of the substance and the lack of exposure potential.

Acute dermal toxicity

A waiver is proposed based on the low acute oral toxicity of the substance.

Justification for classification or non-classification

Based on the available data, the substance does not require classification for acute toxicity.