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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Method: other: BASF-Test
GLP compliance:
no
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
6,10,14-trimethylpentadecan-2-one
EC Number:
207-950-7
EC Name:
6,10,14-trimethylpentadecan-2-one
Cas Number:
502-69-2
Molecular formula:
C18H36O
IUPAC Name:
6,10,14-trimethylpentadecan-2-one
Details on test material:
Purity: unknown
Density: 0.834 g/ml

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, 7950 Biberach, Germany
- Weight at study initiation: male: 268 g, female: 238 g
- Identification: cage cards
- Housing: single housing in stainless steel wire mesh cage (type DK-III, Becker & Co., Castrop-Rauxel, Germany)
- Diet (e.g. ad libitum): KLIBA-Labordiät 343, Klingenthalmühle AG, CH-4303 Kaiseraugst, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
- application area: about 50 cm²
- route of application: single application to the clipped epidermis (dorsal and dorsolateral parts of the trunk)
- clipping of the fur: at least 15 hours before beginning of thy study
- application: in the morning, Aug. 25, 1988
- coverage of the application site with a semiocclusive dressing (four layers of absorbent gauze and porous bandage) for 24 hours
- afterwards: removal of the dressing and rinsing of the application site with warm water
Duration of exposure:
24 h
Doses:
2000 mg/kg bw (= 2,4 ml/kg bw)
No. of animals per sex per dose:
5
Details on study design:
- Duration of observation period following administration: 14 days
- signs and symptoms: recording several times on the day of application and then at least once each workday
- check for moribund and dead animals: twice each workday and once on holidays
- scoring of skin findings: 30-60 min after removal of the semiocclusive dressing and then about one week later and before termination of the study
- pathology: withdrawal of food about 16 hours before sacrifice with CO2; then necropsy with gross-pathological examination; necropsy of all animals that die as early as possible

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none during 24 hours exposure and 14 day observation period
Clinical signs:
symptoms: no abnormalities
erythema: only on day 1 in males and females
Body weight:
mean weight male [g]:
268 day 0
293 day 7
317 day 13

mean weight female [g]:
238 day 0
243 day 7
253 day 13
Gross pathology:
sacrificed animals (male+female): no pathological findings noted

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met