Cyclohexane, oxidized, non-acidic by-products, distn. residues

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

only 8 days observation period

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohexane, oxidized, non-acidic by-products, distn. residues

EC Number:

271-816-4

EC Name:

Cyclohexane, oxidized, non-acidic by-products, distn. residues

Cas Number:

68609-04-1

IUPAC Name:

(1s,4s)-cyclohexane-1,4-diol (cyclohexyloxy)cyclohexane 2-butylcyclohexan-1-one 8-oxatricyclo[7.4.0.0^{2,7}]trideca-1(9),2(7)-diene cyclohexane cyclohexane-1,3-diol cyclohexanol phenol hydrate

Details on test material:

- Name of test material (as cited in study report): Anone destillation residue
- Analytical purity: not reported

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach
- Mean weight at study initiation: male 2.41 Kg, female 2.05 Kg
- Housing: one per cage
- Diet: Kliba 341, about 130 g/animal/day
- Water: 250 ml tap water/animals/day
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin sites of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml undiluted

Duration of treatment / exposure:

4 hour(s)

Observation period:

8 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x2.5 cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and lutrol/water (1:1)
- Time after start of exposure: 4 h


SCORING SYSTEM: Draize scoring. Readings were taken 30-60 min after removal of the test patches, and 24h, 48h, 72h and 8 days after the beginning of the application.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24-48-72 h

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: scaling was observed on day 8 of observation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24-48-72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24-48-72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: scaling was observed on day 8 of observation

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 rabbits

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Any other information on results incl. tables

Animal No.	Erythema
	24 h	48 h	72 h	8 d	24-72 h
1	3	3	2^a	0^b	2.67
2	1	0	0	0	0.33
3	3	2	1^b	0^b	2.00

Animal No.	Edema
	24 h	24 h	24 h	24 h	24 h
1	0	0	0	0	0
2	0	0	0	0	0
3	0	0	0	0	0

a: superficial scurf; b: scaling