Registration Dossier
Registration Dossier
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EC number: 203-841-3 | CAS number: 111-17-1
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3,3'-thiodi(propionic acid)
- EC Number:
- 203-841-3
- EC Name:
- 3,3'-thiodi(propionic acid)
- Cas Number:
- 111-17-1
- Molecular formula:
- C6H10O4S
- IUPAC Name:
- 3-[(2-carboxyethyl)sulfanyl]propanoic acid
- Details on test material:
- - Name of test material (as cited in study report): 3,3´-Thiobispropanoic acid
- Analytical purity: 99.5 %
- Lot/batch No.: MB-311
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent.
- Age at study initiation: approximately eight to twelve weeks old
- Weight at study initiation: approximately 200g
- Housing: The animals were housed in groups of five by sex in solid-floor polypropylene cages with stainless steel lids, furnished with softwood f akes (Datesand Ltd., Cheshire, UK) and provided with environmental enrichment items: wooden chew blocks (B & K Universal Ltd, Hull, UK) and cardboard “fun tunnels” (Datesand Ltd., Cheshire, UK).
- Diet (e.g. ad libitum)+ Water (e.g. ad libitum): Free access to mains drinking water and food (EU Rodent Diet 5LF2, BCM IPS Limited, London, UK) was allowed throughout the study.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 30 - 70%
- Air changes (per hr): fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light and twelve hours darkness
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: shorn skin
- % coverage: approximately 10 % of the body surface
- Type of wrap if used: surgical gauze was placed over the treatment area and semi-occuled with a peace of self-adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated skin and surrounding hair wiped with cotton wool moistured with distilled water to remove any residual test material. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- ten animals (five males and five females)
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality during the study
- Clinical signs:
- other: No signs of systemic toxicity
- Other findings:
- No abnormalities were noted at necropsy.
Any other information on results incl. tables
The acute dermal median lethal dose (LD50) of the test material in the Sparque-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute dermal toxicity study according to OECD TG 402, Sprague-Dawley rats (5/sex/dose) were dermally exposed to 2000 mg/kg bw 3,3'-Thiobispropanoic acid in water for 24 h under semiocclusive conditions. Animals were then observed for 14 d.
No mortality occurred during the study. No signs of systemic toxicity were observed. All animals showed the expected gains in bodyweight over the study period.
The dermal LD50 was >2000 mg/kg bw.
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