Ethyl 2-cyclohexylpropionate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 4 to 18 November 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: it is GLP and according EU method B.3

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl 2-cyclohexylpropionate

EC Number:

412-280-5

EC Name:

Ethyl 2-cyclohexylpropionate

Cas Number:

2511-00-4

Molecular formula:

C11H20O2

IUPAC Name:

ethyl 2-cyclohexylpropanoate

Details on test material:

- Physical state: clear liquid
- Storage condition of test material: 4ºC im the dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River U.K Limited, Margate, Kent, England
- Age at study initiation: 7-10 weeks
- Weight at study initiation: 212-235 g
- Fasting period before study:
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22ºC
- Humidity (%): 59
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light):12/12

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The test substance was applied by spreading it evently over the prepared skin. The treated are (approximately 50 mm x 50 mm) was then promptly covered with gauze which was held in place with an impermeable dressing encircled firmly around the trunk.
At the end of the 24-hour exposure period, the dressing were carefully removed and the treated area of skin was washed with in warm (30º to 40ºC) water and blotted dry with absorbent paper.

Duration of exposure:

24 h

Doses:

2.09 ml/kg

No. of animals per sex per dose:

A group of ten rats (five males and five females) was treated at 2.0 g/kg bodyweight.

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths following a single dermal application of the test substance at 2.0 g/kg bodyweight.

Clinical signs:

other: There were no signs of systemic reaction to treatment

Gross pathology:

MACROSCOPIC EXAMINATION
No macroscopic abnormalities were observed for animals killed on Day 15.

Other findings:

DERMAL RESPONSES
Sites of application of the test substance showed no irritation or other dermal changes (score of zero for erythema and oedema were recorded for all animals)

Any other information on results incl. tables

TABLE 1

Individual bodyweights (g) of rats dosed dermally with the test substance

Sex	Dose	Animal number & ear mark	Bodyweight (g) at
			Day 1	Day 8	Day 15
Male	2	1 RP	225	280	328
		2 LP	232	286	344
		3 RPLP	224	281	345
		4 RIRO	233	290	339
		5 LILO	235	281	337
Female	2	6 RP	212	247	277
		7 LP	217	250	274
		8 RPLP	213	226	250
		9 RIRO	218	246	271
		10 LILO	224	239	260

TABLE 2

Indivual bodyweight changes (g) of rats dosed dermally with the test substance

Sex	Dose	Animal number & ear mark	Bodyweight gains (g) at
			Day 1	Day 8
Male	2	1 RP	55	48
		2 LP	54	58
		3 RPLP	57	64
		4 RIRO	57	49
		5 LILO	46	56
Female	2	6 RP	35	30
		7 LP	33	24
		8 RPLP	13	24
		9 RIRO	28	25
		10 LILO	15	21

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute lethal dermal dose to rats of the tests subatcne was found to be greater than 2.0 g/kg bodyweight

Executive summary:

A study performed to assess the acute dermal toxicity of the test substance tot he rat. The method followed was that described in EEC Methods for the determination of toxicity, Directive 84/449/EEC, Part B, Method B.3. Acute toxicity dermal.

A group of ten rats (five males and five females) was given in a single dermal application of the test substance, as supplied, at a dose level of 2.0 g/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation period.

/There were no deaths and no signs of systemic reactions to treatment.

Site of application of the test substance showed no irritation or other dermal changes.

A slightly low bodyweight gain was recorded for one male on Day 8; this rat achieved an anticipated gain on Day 15. All other rats achieved anticipated bodyweight gains throughout the study.

No obnormalities were recorded at the macroscopic examination on Day 15.

The acute lethal dermal dose to rats of the test substance was found to be greater than 2.0 g/kg bodyweight.

The test substance not require labelling with the risk phrase R "Harmful in contact with skin", in accordance with Council Directive 79/831/EEC Annex VI, Part II (D) as described in Comission Directive 91/325/EEC.