Indeno[4,3a-b]furan, decahydro-2,2,7,7,8,9,9-heptamethyl-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 May 2003 and 11 June 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

449-360-4

EC Name:

-

Cas Number:

647828-16-8

Molecular formula:

C18H32O

IUPAC Name:

decahydro-2,2,6,6,7,8,8-heptamethyl-2H-Indeno[4,5-b] furan

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: Body weights fell within an interval of ± 20% of the mean initial body weight of the first treated group
- Fasting period before study: Overnight fast and for approximately 3 to 4 hours after dosing
- Housing: Groups of 3 in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs continuous light (06:00 to 18:00) and 12 hrs darkness

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED:
2.15 mL/kg

DOSAGE PREPARATION:
For the purpose of the study the test substance was used as supplied. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level.

CLASS METHOD:
- Rationale for the selection of the starting dose: In absence of data suggesting test substance is toxic, 2000 mg/kg was chosen as the starting dose.

Doses:

2000 mg/kg bw

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: 1/2, 1, 2, 4 hours after dosing and subsequently once daily for 14 days. Weighing: prior to dosing and 7 and 14 days after treatment.
- Necropsy of survivors performed: yes.
- Other examinations performed: clinical signs, body weight and gross pathological examination.

Statistics:

None recorded.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Confidence intervals are not applicable in view of the absence of effects.

Mortality:

There were no deaths.

Clinical signs:

other: There were no signs of systemic toxicity.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

None

Any other information on results incl. tables

Table 1. Mortality.

Dose Level mg/kg	Sex	Number of Animals Treated	Deaths During Day of Dosing (Hour)				Deaths During Period After Dosing (Days)								Deaths
			½	1	2	4	1	2	3	4	5	6	7	8-14
2000	Female	3	0	0	0	0	0	0	0	0	0	0	0	0	0/3
	Female	3	0	0	0	0	0	0	0	0	0	0	0	0	0/3

Table 2. Individual Clinical Observations.

Dose Level mg/kg	Animal Number and Sex	Effects Noted After Dosing (Hours)				Effects Noted During Period After Dosing (Days)
		½	1	2	4	1	2	3	4	5	6	7	8	9	10	11	12	13	14
2000	1-0 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	1-1 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	1-2 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2-0 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2-1 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2-2 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Table 3. Individual Body weights and Weekly Body weight Changes.

Dose Level mg/kg	Animal Number and Sex	Body weight (g) at Day			Body weight Gain (g) During Week
		0	7	14	1	2
2000	1-0 Female	223	248	273	25	25
	1-1 Female	222	263	283	41	20
	1-2 Female	242	275	298	33	23
	2-0 Female	213	258	278	45	20
	2-1 Female	214	258	283	44	25
	2-2 Female	236	259	291	23	32

Table 4. Individual Necropsy Findings.

Dose Level mg/kg	Animal Number and Sex	Macroscopic Observations
2000	1-0 Female	No abnormalities detected
	1-1 Female	No abnormalities detected
	1-2 Female	No abnormalities detected
	2-0 Female	No abnormalities detected
	2-1 Female	No abnormalities detected
	2-2 Female	No abnormalities detected

 

Applicant's summary and conclusion

Interpretation of results:

other: Not acute harmful according to EU CLP (EC 1272/2008 and its amendments).

Conclusions:

The substance has an LD50 greater than 2500 mg/kg bw based on Annex 2d of OECD TG 423 and therefore, is not harmful according to CLP.
GHS: For GHS this substance needs to be classified as Acute Tox 5 (H303).

Executive summary:

In an acute oral toxicity study which was performed in accordance with the Acute Toxic Class method (OECD TG 423) and in compliance with GLP, a group of 3 fasted female Sprague-Dawley CD strain rats was treated with the test substance at a dose level of 2000 mg/kg bw. This was followed by a further group of 3 fasted females at the same dose level. The test substance was administered orally undiluted. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. No mortality was observed. All animals showed expected body weight gains over the study period. There were no signs of systemic toxicity and no abnormalities were noted at necropsy. The acute oral median lethal dose (LD₅₀) of the test substance in the female Sprague-Dawley CD strain rat was estimated as being greater than 2500 mg/kg bw, based on Annex 2d of OECD TG 423.