Registration Dossier
Registration Dossier
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EC number: 246-644-8 | CAS number: 25134-21-8
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Although the study pre-dates current test guidelines and GLP regulations, the design follows standard methods for the determination of acute toxicity.
Data source
Reference
- Reference Type:
- grey literature
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Remarks:
- Study pre-dates implementation of GLP regulations
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 1,2,3,6-tetrahydromethyl-3,6-methanophthalic anhydride
- EC Number:
- 246-644-8
- EC Name:
- 1,2,3,6-tetrahydromethyl-3,6-methanophthalic anhydride
- Cas Number:
- 25134-21-8
- Molecular formula:
- C10H10O3
- IUPAC Name:
- 3a,4,7,7a-tetrahydromethyl-4,7-methano-2-benzofuran-1,3-dione
- Details on test material:
- - Name of test material (as cited in study report): TK 10 524 - Nadic methyl anhydride (Hardener HY 906)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAIf
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-house breeding colony
- Age at study initiation: No data
- Weight at study initiation: 155 - 208 g
- Fasting period before study: Overnight
- Housing: Group caged (5 same sex / cage)
- Diet (e.g. ad libitum): Standard rodent diet pellets (Nafag Gossau SG), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23 deg C
- Humidity (%): 50-60%
- Photoperiod (hrs dark / hrs light): 10 hours dark / 14 hour light
IN-LIFE DATES: From: March 1977 To: May 1977
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 100 cm2 / kg body weight
- Type of wrap if used: Occlusive dressing held in place by adhesive elastic 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): 2000, 3000, 4000 and 5000 mg/kg body weight
- Constant concentration used: yes (undiluted) - Duration of exposure:
- 24 hours
- Doses:
- 2000, 3000, 4000 and 5000 mg/kg body weight
- No. of animals per sex per dose:
- 5 males / 5 females / dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 24, 48 and 72 hours and 14 days after dosing; Body weights recorded at test start and termination
- Necropsy of survivors performed: yes - Statistics:
- Probit analysis
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4 920 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 3 670 - 6 590
- Mortality:
- 2000 mg/kg - 0/5 males, 0/5 females
3000 mg/kg - 1/5 males, 1/5 females
4000 mg/kg - 2/5 males, 1/5 females
5000 mg/kg - 2/5 males, 3/5 females - Clinical signs:
- other: 2000 mg/kg - Reduced activity and ataxia seen after 60 minutes. After 3 hours palpebral closure apparent. After 6 hours ventricumbency occurred Palpebral closure and humpbacked posture lasted 2 days. 3000 mg/kg - Reduced activity and ataxia seen after 60
- Gross pathology:
- 2000 mg/kg - No gross organ changes seen
3000 mg/kg – Decedent animals not examined due to cannibalism by cage mates. No gross organ changes seen in surviving animals.
4000 mg/kg – Examination of decedent animals revealed congestion of the lungs, bloody stomach content and petechial haemorrhage on the stomach mucosa. Surviving animals showed no pathology.
5000 mg/kg – As above
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Acute toxicity has been determined in the rat following administration of a single dose to the skin for a 24 hour period. The median lethal dose (LD50) was determined to be 4920 mg/kg body weight.
- Executive summary:
Acute toxicity has been determined in the rat following administration of a single dose to the skin for a 24 hour period. The median lethal dose (LD50) was determined to be 4920 mg/kg body weight.
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