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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: oral
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 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Method: other: BASF-Test
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
Hexahydrofarnesylaceton
Purity: unknown

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: 178 g, female: 179 g
- Identification: cage cards
- no. of animals per cage: 5
- Housing: stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, Germany)
- Diet: KLIBA-Labordiaet 343, Klingenthalmühle AG, CH-4303 Kaiseraugst, Switzerland, ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 1 week
- fasting period: the animals were given no feed about 16 hours before administration, but water was available as libitum

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
- test substance formulation with: 0.5% aquaeous carboxymethyl cellulose, corresponding to physiological medium
- time of day of administration: morning (Aug. 9, 1988)
Doses:
2000 mg/kg bw
conc.: 200 mg/ml
administered volume: 10 ml/kg bw
No. of animals per sex per dose:
5
Details on study design:
- Duration of observation period following administration: 14 days
- signs ans symptoms: several times on the day of administration, then at least once each workday
- check for moribund and dead animals: twice each workday and once on holidays
- pathology: withdrawal of food about 16 hours before sacrifice with CO2, then necropsy with gross-pathological examination

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 after single administration and during 14 day observation period
Clinical signs:
no abnormalities
Body weight:
mean weight males:
day 0: 178 g
day 7: 245 g
days 13: 275 g

mean weight females:
day 0: 179 g
day 7: 210 g
days 13: 221 g
Gross pathology:
sacrificed animals: male + female
no pathological findings noted

Any other information on results incl. tables

No symptoms, no pathologic findings in sacrificed animals.

Applicant's summary and conclusion

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