1,3- AND 1,4-CYCLOHEXANDICARBOXYALDEHYDE

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP/Guidline Study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Annex V

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: MAFF 59 NohSan No. 4200

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

482-020-3

EC Name:

-

Molecular formula:

C8H12O2

IUPAC Name:

cyclohexane-1,3-dicarbaldehyde; cyclohexane-1,4-dicarbaldehyde

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report):Consolidated Cyclohexane Dicarboxaldehydes
- Physical state:liquid
- Impurities (identity and concentrations): Cyclohexanecarboxaldehyde 0.28%, Hydroxyaldehyde 0.23%, Unknowns 0.51%
- Lot/batch No.:9-CWDY-50-O 1
- Storage condition of test material: ambient

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA
- Age at study initiation: Young adult
- Weight at study initiation: 2622 to 2654 grams
- Housing: Individual suspended wire-mesh cages.
- Diet (e.g. ad libitum): PMI Nutrition International, Inc. Certified Rabbit LabDiet® 5322 was offered at approximately 150 g per day during the study.
- Water (e.g. ad libitum): municipal water ad libitum
- Acclimation period: The animals were acclimated to laboratory conditions for a minimum of seven days prior to initiation of dosing.

ENVIRONMENTAL CONDITIONS
- Temperature: 66-71°F
- Humidity (%): 30-68%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

IN-LIFE DATES: From: 2001-02-14 to 2001-02-23

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 h

Observation period:

Application sites were evaluated in accordance with the method of Draize at approximately 30-60 minutes adn 24,48 and 72 hours after patch removal and daily through study day 9, if irritation persisited.

Number of animals:

3

Details on study design:

There was one group of three albino rabbits that received a single, four-hour, semi-occluded exposure. Each 0.5-ml dose of the test article was applied to the clipped, unabraded skin. At completion of exposure, the bandages were removed and the sites washed.

Application sites were evaluated in accordance with the method of Draize at approximately 30-60 minutes adn 24,48 and 72 hours after patch removal and daily through study day 9, if irritation persisited.

Body weights were obtained and recorded on study day 0 (initiation) and at each rabbit's termination from the study.

Upon termination, the rabbits were euthanized by intravenous injection of euthanasia solution and discarded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

1.3

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

1

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

2

Results 4

Irritation parameter:

erythema score

Max. score:

2

Remarks on result:

other: Max. duration: 96 d; Max. value at end of observation period: 0 (related to all animals)

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 8

Irritation parameter:

edema score

Max. score:

0

Remarks on result:

other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 9 days

Other effects:

Grade 2 erythema was still apparent in one animal at 96 hour s.

Any other information on results incl. tables

There were no deaths during the study.

There were no remarkable body weight changes noted during the study.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

All animals were noted with very slight to slight erythema which completely subsided by termination (study day 9). Two animals were noted with desquamation, which persisted through each animal’s termination (study days 7 or 9). There was no edema, nor were there any other cutaneous findings.

Executive summary:

The primary skin irritation potential of Consolidated Cyclohexane Dicarboxaldehydes was evaluated in this study with New Zealand White rabbits. There was one group of three albino rabbits that received a single, four-hour semi-occluded exposure. Each 0.5 -

ml dose of the test article was applied to the clipped unabraded skin. At completion of exposure, the bandages were removed and the sites washed. Application sites were evaluated in accordance with the method of Draize at approximately 30-60 minutes and 24, 48, and 72 hours after patch removal and daily through study day 9, if irritation persisted. All animals were noted with very slight to slight erythema which completely subsided by termination (study day 9). Two animals were noted with desquamation, which persisted through each animal’s termination (study days 7 or 9). There was no edema, nor were there any other cutaneous findings. The primary Irritation Index (PII)( was 1.5. The test article, Consolidated Cyclohexane Dicarboxaldehydes, received a descriptive rating classification of slightly irritating.