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Description of key information

LD 50 oral > 2000 mg/kg

LD50 dermal > 2000 mg/kg

No acute inhalation study available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
Degree of purity: 95.4%
Physical condition: Liquid
Lot number: 8906-87
Species:
rat
Strain:
other: Ibm: RORO (SPF)
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
other: none
Gross pathology:
no effects
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral toxicity of benzenepropanal, .beta.-methyl-3-(1-methylethyl)- is greater than 2000 mg/kg bodyweight in male and female rats.
Executive summary:

Ten outbred stock, Ibm: RORO (SFP) animals (5 males and 5 females) were used. Animals were approximately 5-6 weeks old. Males weighed 107-131 grams and females weighed 112-119 grams. Animals wer housed individually in an air conditioned room. Room temperature was 20-24 C with relative humidity of 45-65% and an artificial light cycle of 12 hour darkness and 12 hours light per day. Food and water were available ad libitum except 18 hours prior to dosing where the animals were fasted. A single dose of test material in Standard Suspending Vehicle (SSV) was administered to each animal. Animals were observed for daily for 15 days for toxic signs including mortality and body weight changes. Bodyweights were recorded on days 0, 4, 7, 12 and 15. Gross necropsies were conducted on all animals

100 ml SSV contained: 5 grams sodium carboxymethyl cellulose of median viscosity, 4 ml Tween 80, 5 ml benzylalcohol pro analysi, 9 grams sodium-chloride pro analysi, aqua destillata ad 1000 ml.

The acute oral toxicity of benzenepropanal, .beta.-methyl-3-(1-methylethyl)- is greater than 2000 mg/kg bodyweight in male and female rats. No deaths occurred. No effect on bodyweight was observed. No findings at necropsy.       

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Klimisch 1, guideline and GLP study

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes
Specific details on test material used for the study:
Batch number: 183831
Species:
rat
Strain:
other: Ibm: RORO (SPF)
Sex:
male/female
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Duration of exposure:
14 days
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

Ten Outbred stock IBM: RORO(SPF) (5 male and 5 female) animals were used. Animals weighed approximately 180-250 grams at the start of the study. Animals received food and water ad libitum. Animals were housed individually in stainless steel wire mesh cages, Type III. The animal room temperature was 22 C +/- 2 C, relative humdity was 55% +/- 10% with a 12 hour fluorescent light/dark cycle. One day prior to treatment an area of approximately 5 x 5 cm on the back of the animals was clipped free of hair. On treatment day, a single dose of test material was applied onto the clipped skin area of each animal. The substance was covered with cotton gauze and impermeable paper and fixed with an abdominal occlusive dressing. The dressing remained in place for 24 hours after which time it was removed and the residual test material was removed by cleaning the application site. Animals were observed for clinical symptoms and mortalities daily for 14 days. Bodyweights were monitored twice per week. Necropsies were conducted at the end of the study following withdrawal of feed for 12-20 hours. Tissue from the application site and untreated skin was removed for histopathological examination

Compliance: OECD Guidelines for Testing of Chemicals, Ad. 2/24/87; section 4: health effects, part No. 402: acute dermal toxicity-limit test.

The acute dermal median lethal dose (LD50) was greater than 2000 mg/kg bodyweight in male and female rats. No treatment-related alterations or overt signs of toxicity were observed during the study. No treatment-related alterations were observed at necropsy. The histopathological revealed no signs of skin irritation on the application sites.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Klimisch 1, guideline and GLP study

Additional information

Justification for classification or non-classification

According to the test results available, the substance does not need any classification under CLP for acute toxicity.