Registration Dossier
Registration Dossier
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EC number: 939-688-0 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05-JAN-2005 - 26-JAN-2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- (31 July 1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- (24 February 1987)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, C16-18 (even numbered), reaction products with tetraethylenepentamine, acetates (salts)
- EC Number:
- 939-688-0
- Molecular formula:
- Not applicable
- IUPAC Name:
- Fatty acids, C16-18 (even numbered), reaction products with tetraethylenepentamine, acetates (salts)
- Test material form:
- other: solid
- Details on test material:
- - Name of test material: Fatty acids, C16-18, reaction products with tetraethylenepentamine, acetates (salts)
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Fatty acids, C16-18, reaction products with tetraethylenepentamine, acetates (salts)
Test animals
- Species:
- rat
- Strain:
- other: HanBrl: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, CH-4414 Fillinsdorf / Switzerland
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Males: 8 weeks, Females: 12 weeks
- Housing: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding during treatment and observation.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 42/04 (Provimi Kliba AG, CH-4303 Kaiseraugst/ Switzerland) ad /ibitum.
- Water (e.g. ad libitum): Community tap water from Fillinsdorf ad libitum.
- Acclimation period: 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- (deionised, purified)
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Mortality / Viability: Daily during the acclimatization period, at approximately 1, 2, 3 and 5hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15.
- Body weights: On test days 1 (prior to administration), 8 and 15.
- Clinical signs: Daily during acclimatization and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 in rats (male/female) of C16-18FA-TEPA-compound was > 2000 mg/kg bw.
- Executive summary:
In an acute dermal toxicity study according to OECD guideline 402 (24 February 1987) and EU method B.3 (31 July 1992), groups of young adult HanBrl: WIST rats (5/sex) were dermally exposed to C16 -18FA-TEPA-compound in purified water for 24 hours to approx. 10% body surface area at a limit dose of 2000 mg/kg bw. Animals then were observed for 14 days. The test substance was applied as solution of 0.33 g/mL.
No deaths occurred during the study. The only clinical signs noted were slight general erythema in five males and four females on day 2 which persisted up to day 3, 5, 7 and 8 in the male and up to day 4, 5 and 8 in the female animals and slight swelling on day 2 in one female. The body weight was within the range commonly recorded for this strain and age. No macroscopic abnormalities were observed at necropsy.
Dermal LD50 male/female > 2000 mg/kg bw
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