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:

From 7 JUNE 1977 to 12 AUGUST 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study was conducted prior to GLP and OECD guidelines but was conducted according to acceptable procedures at the time.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Shorter observation time than recommended in OECD guideline 401: 7 days vs. 14 days

GLP compliance:

not specified

Remarks:

This study was prior to GLP and OECD guidelines but was conducted according to acceptable procedures at the time.

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): Galaxolide 50
- Date received: 7/15/77
- Physical state: A clear liquid
- Lot/batch No.: SG-087-2030
- Purity: Assumed 50% active

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 104-141 grams
- Fasting period before study: YES, overnight

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

0.215, 0.464, 1.0, 2.15 and 4.64 g/kg bw Galaxolide 50, equivalent to doses of HHCB of 0.14, 0.30, 0.65, 1.4 and 3.0 g/kg when corrected for the 65% dilution).

No. of animals per sex per dose:

5 females per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Immediately after dosing at one, four and 24 hrs and once daily thereafter for a total of 7 days.
- Necropsy of survivors performed: yes

Statistics:

Mortality data was analyzed statistically, utilizing the tables of Horn, HJ. Biometrics 12, 311, 1956.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 4 640 mg/kg bw

Remarks on result:

other: The LD50 was >3 g/kg BW expressed in HHCB equivalents.

Mortality:

There was one death as a result of gavage error at 1.0 g/kg but no deaths at any other dose

Clinical signs:

One animal at 2.15 g/kg appeared distressed shortly after dosing but appeared normal after 2h. There were no effects at the high dose.

Any other information on results incl. tables

Table 1: mortaility in the study.

			Time of death	Time of death
Dose (g/kg)	Concentration (%)	Immediate	Hours (1-24)	Days (2-7)
0.215	100	0/5	0/5	0/5
0.464	100	0/5	0/5	0/5
1	100	0/5	1/5	1/5
2.15	100	0/5	0/5	0/5
4.64	100	0/5	0/5	0/5

LD50= >4.64 g/kg total product

Since 50% active LD50= >2.15 g/kg

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The material does not need to be classified for acute oral toxicity.

Executive summary:

Galaxolide 50 (Non-GLP; 65% HHCB in diethyl phthalate (DEP)) was administered undiluted (hence, there was variation in volume of dosing) by oral intubation at doses of 0.215, 0.464, 1.0, 2.15 or 4.64 g/kg bw (equivalent to doses of HHCB of 0.14, 0.30, 0.65, 1.4, 3.0 g/kg when corrected for the 65% dilution) to groups of 5 female Charles River Sprague Dawley rats (initial bodyweight 104–141 grams) that were then observed for mortality and signs of effects for 7 days. There was one death as a result of gavage error at 1.0 g/kg but no deaths at any other dose. One animal at 2.15 g/kg appeared distressed shortly after dosing but appeared normal after 2 hr. There were no effects at the high dose. An LD₅₀of >4.64 g/kg bw (equivalent to >3 g/kg bw HHCB) was calculated. This study was conducted prior to GLP and OECD guidelines but was conducted according to acceptable procedures at the time.