1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran

Acute Toxicity: oral

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

Test material information

Constituent 1

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.