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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
β-methyl-3-(1-methylethyl)benzenepropanal
EC Number:
412-050-4
EC Name:
β-methyl-3-(1-methylethyl)benzenepropanal
Cas Number:
125109-85-5
Molecular formula:
C13H18O
IUPAC Name:
3-[3-(propan-2-yl)phenyl]butanal
Test material form:
liquid
Specific details on test material used for the study:
Batch number: 183831

Test animals

Species:
rat
Strain:
other: Ibm: RORO (SPF)
Sex:
male/female

Administration / exposure

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

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

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.