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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 Aug 2016 - 28 Okt 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
17 December 2001
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran
EC Number:
214-946-9
EC Name:
1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran
Cas Number:
1222-05-5
Molecular formula:
C18H26O
IUPAC Name:
4,6,6,7,8,8-hexamethyl-1H,3H,4H,6H,7H,8H-indeno[5,6-c]pyran
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER LABS
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Age at study initiation: 8 weeks
- Fasting period before study: food was removed on D1 and then redistributes 4 hours after the test item administration.
- Housing: In groups of three in polycarbonate cages with sawdust bedding.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Air changes (per hr): at least ten per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.09 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: corresponding to 2g/kg according to the calculated density
Doses:
2.09 mL/kg bw, 2000 mg/kg bw (according to calculated density)
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observation Daily, Weighing on Day 0, 2, 7, 14
- Necropsy of survivors performed: yes , macroscopic
- Other examinations performed: behavioural, clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None.
Clinical signs:
other: None.
Gross pathology:
Macroscopic examination did not reveal treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:
other: Not harmful
Remarks:
in accordance with EU CLP (EC no 1272/2008 and its amendments)
Conclusions:
The substance has an LD50 of > 2000 mg/kg bw in an OECD TG 423 test.
Executive summary:

The substance is tested in an acute toxic class method test (OECD TG 423, GLP) on a group of six female rats at a dose of 2000 mg/kg bw. No mortality occurred during the study, and no clinical signs related to the test item were observed durng the 14 -day observation period. Bodyweights were observed and remained normal, except for one animal. Macroscopy did not reveal any treatment related changes. The LD50 result in >2000 mg/kg bw.

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