Registration Dossier
Registration Dossier
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EC number: 203-614-9 | CAS number: 108-77-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-07-12 to 1988-07-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: - Guideline study with acceptable restrictions (e.g. size of application area not reported)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- as at 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- as at 1984
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- study performed prior to implementation of GLP
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,4,6-trichloro-1,3,5-triazine
- EC Number:
- 203-614-9
- EC Name:
- 2,4,6-trichloro-1,3,5-triazine
- Cas Number:
- 108-77-0
- Molecular formula:
- C3Cl3N3
- IUPAC Name:
- trichloro-1,3,5-triazine
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Russian White (albino)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Asta Pharma AG, D-4800 Bielefeld 14
- Age at study initiation: 18 - 24 weeks (males) 22 - 24 weeks (females)
- Weight at study initiation: 2.19 - 2.31 kg (males), 2.49 - 2.65 kg (females)
- Fasting period before study: food withheld at day of application start
- Housing: 1 per cage (stainless steel cages model ASTA, ASTA Pharma AG, D-4800 Bielefeld 14)
- Diet: not reported
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22
- Humidity (%): 45 - 65
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- paraffin oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: between shoulder and os sacrum
- % coverage: not reported
- Type of wrap if used: not reported
REMOVAL OF TEST SUBSTANCE
- Washing: with water
- Time after start of exposure: 24 h
TEST MATERIAL
- Constant volume or concentration used: yes
- For solids, paste formed: yes, 1g of test substance moistured in 0.567 ml paraffin oil (vehicle) - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 4-8 h post application, daily thereafter; Frequency of weighing: day 1, day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology of skin of the application site, other: gross necroscopy - Statistics:
- - not applicable as no deaths occurred during the test procedure
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- - no deaths occurred during the test period
- Clinical signs:
- other: - No systemic toxicity. At the application site: red/brown staining, swelling and hardening - Staining and swelling reversed between day 8 and day 13
- Gross pathology:
- - no lesions in internal organs were found
- Pathology findings in the skin at the application site included: acanthosis, hyperkeratosis, subepidermal mixed inflammatory cell infiltration, erosion, superficial exudate, subepidermal haemorrhages, ulceration, epidermal proliferation, secondary built hairfollicle cysts, epidermal necrosis and slight pustule forming
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this acute dermal toxicity study a combined LD50 for both sexes of > 2000 mg/Kg was deduced in rabbits.
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