Registration Dossier
Registration Dossier
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EC number: 247-570-9 | CAS number: 26266-63-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2016-09-26 to 2016-10-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Tetrahydrophthalic anhydride
- EC Number:
- 247-570-9
- EC Name:
- Tetrahydrophthalic anhydride
- Cas Number:
- 26266-63-7
- Molecular formula:
- C8H8O3
- IUPAC Name:
- tetrahydro-2-benzofuran-1,3-dione
- Test material form:
- solid - liquid: suspension
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material: Sample from production lot
- Lot/batch No.of test material: Lab sample of October 9th 2015
- Expiration date of the lot/batch: 2016-10-08
- Purity: 99.91%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient conditions
- Stability under test conditions: Stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS srl, San Pietro al Natisone, Italy
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 7 - 9 weeks
- Weight at study initiation: Males: 253 - 274 g; Females 208 - 220 g
- Fasting period before study: No
- Housing: Individually caged
- Diet (e.g. ad libitum): Commercial rodent diet, ad libitum
- Water (e.g. ad libitum): Municipal supply tap water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 deg C
- Humidity (%): 40 - 70 %
- Air changes (per hr): 15 20
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 2016-09-26 To: 2016-10-11
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Approximately 5 x 7 cm
- % coverage: Approximately 10% of body surface
- Type of wrap if used: Elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, warm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw
- Constant volume or concentration used: Yes, fixed concentration (100%) - Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 Males / 5 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Examined at least daily. Body weight determined weekly
- Necropsy of survivors performed: Yes
- Statistics:
- n/a
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred
- Clinical signs:
- other: Systemic effects: None observed Local effects: All animals showed fissuration and/or desquamation and/or scabs on the treated skin. Recovery has occurred by the end of the 14-day post-dose observation period
- Gross pathology:
- No abnormalities observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The lack of mortality demonstrates the LD50 to be greater than 5000mg/kg.
- Executive summary:
The acute toxicity of THPA (tetrahydrophthalic anhydride) has been investigated following dermal administration of a single dose to the rat at a level of 5000mg/kg.
No mortality occurred following dosing and no clinical signs were noted indicative of systemic toxicity. Local (irritant) effects were observed, recovery occurring within 14 days.
The lack of mortality demonstrates the LD50 to be greater than 5000mg/kg.
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