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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 7 JUNE 1977 to 12 AUG 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study was carried out prior to GLP and OECD guidelines but was conducted according to acceptable procedure at that 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 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Animals used where lighter than described in OECD guideline 402. 108 - 187 grams vs 200 - 300 grams

GLP compliance:

not specified

Remarks:

This study was carried out prior to GLP and OECD guidelines but was conducted according to acceptable procedures at that 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
- The material as tested was a commercial sample containing 65% HHCB in diethyl phthalate (DEP). The actual LD50 value for HHCB is therefore equivalent to > 6500 mg/kg bw.
- 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:

Initial bodyweight 108-187 g

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Duration of exposure:

7 days

Doses:

0.464, 1.0, 2.15, 4.64 and 10.0 g/kg bw Galaxolide 50, equivalent to doses of HHCB of 0.30, 0.65, 1.4, 3.0 and 6.5 g/kg when corrected for the 65% dilution

No. of animals per sex per dose:

5

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:

> 10 000 mg/kg bw

Remarks on result:

other: The LD50 was > 6500 mg/kg BW expressed in HHCB equivalents.

Mortality:

There were no deaths at any dose.

Clinical signs:

All animals in the high dose group exhibited urine staining on their fur.

Gross pathology:

There were no major effects noted in any of the animals in any dosage level.

Any other information on results incl. tables

Table 1: Mortalility in the study.

		Time of death	Time of death	Time of death
Dose (g/kg)	Concentrations (%)	Immediate	Hours (1 -24)	Days (2 -7)
0.464	100	0/5	0/5	0/5
1	100	0/5	0/5	0/5
2.15	100	0/5	0/5	0/5
4.64	100	0/5	0/5	0/5
10	100	0/5	0/5	0/5

LD50= > 10 g/kg total product

Since 50% active, LD50 = > 5 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 dermal toxicity

Executive summary:

Galaxolide 50 (65% HHCB in DEP) was administered undiluted by inunction to the shaved skin (area not reported) of groups of five female Charles River Sprague Dawley rats (initial bodyweight 108–187 g) in doses of 0.464, 1.0, 2.15, 4.64 or 10.0 g/kg bw (equivalent to 0.30, 0.65, 1.4, 3.0, 6.5 g/kg HHCB) that were then observed for 7 days. There were no deaths at any dose but all animals in the high dose group exhibited urine staining on their fur. A dermal LD₅₀ of >10.0 g/kg bw (equivalent to >6.5 g/kg bw HHCB) was reported (Minner and Foster, 1977). This study was conducted prior to GLP and OECD guidelines but was conducted according to acceptable procedures at the time.