Registration Dossier
Registration Dossier
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EC number: 217-210-5 | CAS number: 1777-82-8
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-07-01 to 1997-07-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Experimental study according to guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1100 (Acute Dermal Toxicity)
- Version / remarks:
- 1985
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Pesticide Assessment Guidelines, Subdivision F. Hazard Evaluation: Human and Domestic Animais 81-2 Acute dermal toxicity study (Revised Ed. November 1984). Subdivision F provides information on data requirements of 40 CFR Part 158 and supports FIFRA.
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,4-dichlorobenzyl alcohol
- EC Number:
- 217-210-5
- EC Name:
- 2,4-dichlorobenzyl alcohol
- Cas Number:
- 1777-82-8
- Molecular formula:
- C7H6Cl2O
- IUPAC Name:
- (2,4-dichlorophenyl)methanol
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: Harlan UK Ltd., Bicester, Oxon, England
- Age at study initiation: 11 weeks
- Weight at study initiation: 210 to 254 g
- Fasting period before study: no
- Housing: 5 animals per cage (same sex), metal cages with wire mesh floors
- Diet: ad libitum, Special Diet Services RM 1 (E)SQC expanded pellet
- Water: ad libitum
- Acclimation period: min. 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 40-64
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: 1 % (w/v) aqueous methylcellulose
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorso-lumbar region (approximately 50 mm x 50 mm)
- % coverage: approximately 10 % of total body surface
- Type of wrap: porous gauze held in place with a non - irritating dressing, covered by a waterproof dressing, encircled firmly around the trunk of the animal
REMOVAL OF TEST SUBSTANCE
- Washing: warm water (30 to 40 °C)
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 4 mL/kg bw (test material in vehicle)
- Concentration: 50 % w/v
- Constant volume or concentration used: yes
VEHICLE
- Amount applied: 4 mL/kg bw (test material in vehicle)
- Concentration: 1 % w/v - 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
- Frequency of observations and weighing: Animals were observed after dosing and at frequent intervals for the remainder of Day 1. Afterwards animals were observed once in the morning and once in the aflernoon (Day 15 - morning only). Body weight was recorded on day 1 (before treatement), day 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, dermal responses - Statistics:
- No statistical analysis was performed.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- No clinical signs were observed.
- Body weight:
- Body weight gain was in the normal range.
- Gross pathology:
- No abnormalities were observed.
- Other findings:
- Dermal response:
very slight erythema (grade 1) was detected in 4 animals after removal (day 2). In 3 animals no signs were detected on day 3. In one animal it was detected till day 5, accompanied by desquamation (day 2 to 7). Afterwards no further dermal responses were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information
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