(3E)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not applicable

Principles of method if other than guideline:

- Principle of test: Male and female rats were exposed to the test item in peanut oil DAB 7 (1:1). The treatment was applied to shaved skin and kept under occlusion for 24 hours. The treated area was then washed with water and rats were observed for 14 days.
- Short description of test conditions: Experimental conditions were maintained at 23 to 33 °C with 45 to 75 % relative humidity. Five male and five females rats were used per treatment and control. Animals were individually caged and provided with food and water ad libitum.
- Parameters analysed / observed: Mortality, intoxication symptoms, local changes, body weight

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(3E)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one

EC Number:

701-394-3

Cas Number:

1782069-81-1

Molecular formula:

C18H22O

IUPAC Name:

(3E)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one

Test animals

Species:

rat

Strain:

other: Wistar-AF/HAN-EMD-SPF

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 125 to 143 g (mean 137 g)
- Housing: Individually caged in wire cages Type III.
- Diet (e.g. ad libitum): Altromin R, ad libitum.
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 to 33 °C
- Humidity (%): 45 to 75 %

Administration / exposure

Type of coverage:

occlusive

Vehicle:

peanut oil

Remarks:

DAB 7

Details on dermal exposure:

TEST SITE
- Area of exposure: 6 x 6 cm
- Type of wrap if used: The treated skin area was covered with tin foil, which was fixed and sealed with the aid of a rubber sleeve.

REMOVAL OF TEST SUBSTANCE
- Washing: Yes, substance residues were washed off with water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 10 mL/kg body weight
- Concentration: 50%
- Constant volume or concentration used: Constant concentration used.

VEHICLE
- Amount(s) applied: 10 mL/kg bodyweight
- Concentration: 50%

Duration of exposure:

24 hours

Doses:

10 g/kg body weight

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All rats were observed and weighed daily, Monday through Friday.
- Other examinations performed: Evaluation of the changes occurring in the application area was made according to Draize.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortalities were recorded.

Clinical signs:

other: There were no signs of absorptive intoxication and no symptoms of irritation were observed.

Gross pathology:

No pathoanatomical abnormalities were observed.

Any other information on results incl. tables

Table 1. Body weights

Dose (mg/kg)	Sex	Mean body weight (g)						Difference of final weight from starting weight (g)
		0 days	1 day	3 days	7 days	10 days	14 days
Vehicle	Male	139	123	132	154	168	187	+48
Vehicle	Female	142	126	139	148	157	166	+24
10000	Male	133	117	129	152	165	186	+53
10000	Female	141	126	136	145	153	161	+20

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

The dermal LD50 in rats was determined to be > 10000 mg/kg bodyweight.

Executive summary:

The acute dermal toxicity of the test item was determined in a 14 -day limit test. A nominal concentration of 10 g/kg bodyweight test item in peanut oil DAB 7 (1:1) was applied to a 6 x 6 cm area of shaved skin of male and female Wistar-AF/HAN-EMD-SPF rats. A vehicle control was included in the study. The treated area was occluded for 24 hours, after which substance residues were washed off with water. Rats were observed for mortality, intoxication, local changes and body weight. The LD50 was determined to be > 10 g/kg bw. There were no signs of absorptive intoxication, symptoms of irritation or pathoanatomical abnormalities. All rats lost weight in the first two days after application, however weight gain was continuous thereafter. This study is considered reliable with restriction (Klimisch 2) as the test was conducted similar to OECD Guideline 402, with minor limitations in reporting.