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Toxicological information

Acute Toxicity: dermal

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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: Comparable to guideline standards with acceptable restrictions (3 animals/sex/dose, no GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(limit test)
Deviations:
yes
Remarks:
- 3 animals/sex/dose were employed. Guideline recommends 5/sex/dose.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name as cited in document: Lilial
- Analytical purity: 99%
- Batch No.: not reported
- Physical state: liquid

Test animals

Species:
rat
Strain:
other: Sprague Dawley, Wiga
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Diet: Herilian MRH

ENVIRONMENTAL CONDITIONS
- no further details given

Administration / exposure

Type of coverage:
occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Details on dermal exposure:
TEST SITE
- Area of exposure: Back, 50cm2
- % coverage: no data
- Type of wrap if used: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

TEST MATERIAL
- Amount(s) applied: 2.12 ml/kg bw
- Concentration: 100%

VEHICLE
- Concentration (if solution): 0.5%

Duration of exposure:
not reported
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: 1h, 24h, 48h, day 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: No mortalities occured within 14 days at a dose of 2000 mg/kg bw
Mortality:
No animal died.
Clinical signs:
- Dyspnea, agitation, apathy, staggering, rough fur coat, lacrimation, poor general condition. A questionable reddening of the skin and slight edema was seen after 24 h. After 7 days desquamation was recorded. At the end of the observation period, all symptoms had disappeared.
Body weight:
- Average body weight on day 0; 275g (male), 185g (female). Day 7; 305g (male), 213.7 (female). Days 13; 326g (male), 224 (female)
- Average body weight at necropsy; 280g (male), 197g (female)
Gross pathology:
- No adverse pathological effect was observed

Applicant's summary and conclusion