Alcohols, C12-14-secondary, .beta.-(2-hydroxyethoxy)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD) (test substance purity not specified).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

adopted 29 Dec, 1992

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C12-14-secondary, β-(2-hydroxyethoxy)

EC Number:

308-219-6

EC Name:

Alcohols, C12-14-secondary, β-(2-hydroxyethoxy)

Cas Number:

97926-05-1

IUPAC Name:

97926-05-1

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Epicol G24 G2, C12/14alpha-Epoxid, ringgeöffnet mit Glykol, SAT970397
- Physical state: colorless, transparent fluid
- Analytical purity: not specified
- Lot/batch No.: 10017020
- Expiration date of the lot/batch: 1997-01-20
- Storage condition of test material: room temperature, darkness

Test animals

Species:

rabbit

Strain:

other: SPF albino, Mol:Russian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre A/S, Lille Skensved, Danmark
- Weight at study initiation: 2.3 - 2.5 kg
- Housing: single housing in PPO cages
- Diet: pelleted complete rabbit diet, altromin 2123, ad libitum
- Water: domestic quality drinking water, acidified with hydrochloric acid to pH 2.5, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 55 ± 15 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated site of the same animal served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

21 days
reading time points: 1, 24, 48, 72 hours and 7, 14 and 21 days after removal of the test substance

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm on the back
- Type of wrap if used: gauze patches secured with Gothaplast tape and fixed wrapping the tape around the trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with soap and lukewarm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize Scoring System

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1+#2

Time point:

other: mean over 24, 48 and 72 hours

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 hours

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 hours

Score:

2.33

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 hours

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 5

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 hours

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 21 days

Irritant / corrosive response data:

One hour after termination the first animal showed a well-defined erythema and a very slight edema. The second animal showed very slight edema and erythema and the third animal showed very slight erythema. All animals showed severe to well-defined erythema and only slight edema. After 48 hours all animal showed erythema and edema ranging from slight to severe. At 72 hours all animals showed moderate to severe erythema and only slight edema. On day 7 scale formation of the whole area was seen for all animals. After 14 days scales were still visible. After 21 days normal hair growth and intact skin were found for all animals.

Any other information on results incl. tables

Table1: Overview of individual scores

Observation time	Rabbit No.
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	2	1	1	1	1	0
24 h	3	3	3	3	2	2
48 h	3	2	3	3	2	2
72 h	3	2	3	2	2	2
mean 24 - 72 h	3	2.33	3	2.67	2	2
mean 24 - 72 h all animals	2.67	2.33

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

DSD: Xi, R38
CLP: Category 2, H315