Registration Dossier

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: In principle the test fulfiled the requirements of the OECD guideline 402, but some details were not reported including the age of animals as well as further details on test animals and environmental conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3-Methyl-2-butenal, CAS: 107-86-8
- Analytical purity: purity ca. 98%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: WIGA
- Weight at study initiation: mean body weight males: 218 g, females: 186 g
- Diet: Herilan MRH



Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 42 cm²

TEST MATERIAL
- Concentration (if solution): 100 %
- Constant volume or concentration used: no
Duration of exposure:
14 days
Doses:
1200, 1600, 2000, 2500, 3200, 4000 mg/kg bw
No. of animals per sex per dose:
5 (except 2000 mg/kg dosing group: 6 animals per sex)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 1h, day 1, then daily on working days
- Frequency of weighing: d 0, 4, 6, 11, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology
Statistics:
Probit analysis

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 400 mg/kg bw
Mortality:
1200 mg/kg bw: 0/5 males died after 14 days, 1/5 female died after 24 hrs
1600 mg/kg bw: 0/5 males died after 14 days, 3/5 females died after 24 hrs, 1 additional female after 7 days
2000 mg/kg bw: 3/6 males died after 24 hrs, 1 additional male after 7 days 0/6 females died 14 days
2500 mg/kg bw: 1/5 males died after 24 hrs, 1 additional male after 7 days, 1/5 females died after 7 days
3200 mg/kg bw: 3/5 males died after 24 hrs, 1 additional male after 48 hrs, 2/5 females died after 24 hrs, 1 additional female after 14 days
4000 mg/kg bw: 3/5 males died after 7 days, 1/5 females died after 7 days
Clinical signs:
Poor condition, apathy, dyspnoea, staggering, unsteady gait, abdominal position, paresis was seen in dosed animals. Local skin effects after 24 hrs comprised substance-induced staining and intense swelling, and necrosis after 48 hrs.
Body weight:
no data
Gross pathology:
Acute heart dilatation on both sides of the organ and acute heart congestion. Peripheral lobular pattern in liver in some victims. No changes noted in survivors.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU