Reaction mass of tridecanal and 2-methyldodecanal and pentadecanal and 2-methyltetradecanal

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 26 FEB 1985 to 5 MAR 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Baisc data given: comparable to guidelines Read-across hypothesis: for details please see read-across report in IUCLID section 13

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

: no substance composition or purity stated, no statement given concerning results for day 14 observation

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

112-44-7 + 19009-56-4

IUPAC Name:

112-44-7 + 19009-56-4

Constituent 2

Reference substance name:

n-Undecanal + 2-methyldecan-1-al

IUPAC Name:

n-Undecanal + 2-methyldecan-1-al

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Rosemead Rabbits Limited, Lea Valley, UK
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.3 to 2.43 kg
- Housing: suspended metal cage, individually
- Diet: standard laboratory diet (Rabbit Diet, A. W. Tindall Limited, Holbeach, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 2
- Humidity (%): 45-55
- Air changes (per hr): ~ 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipping

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked with lukewarm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to guideline OECD 404

READING TIMES: 1, 24, 48, 72 hours after removal of the patches, if irritation persisted further observations were made 7 days and 14 days following removal of the patches

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

: total scores for erythema and edema divided by 6

Time point:

other: 24 and 72 h

Score:

5.5

Reversibility:

no data

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of all three animals; individual scores per animal: 3/3/2.67

Time point:

other: 24-48-72 h

Score:

ca. 2.89

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: reactions were extending beyond the site of application

Results 3

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all three animals; individual scores per animal: 2/3.34/3.34

Time point:

other: 24-48-72 h

Score:

ca. 2.89

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: reactions were extending beyond the site of application

Irritant / corrosive response data:

Additionally to erythema and edema desquamation was seen in two animals at 72 h. At day 7 hyperkeratinization with some flaking from affected areas was also evident in all three animals.

Any other information on results incl. tables

Read-across justification: for details please see read-across report in IUCLID section 13

After patch removal:

- 1 h: very slight erythema (score 1/1/1) and very slight or slight edema (score 2/2/1), with reactions extending beyond application site

- 24 h: moderate erythema (score 3/3/3) and slight or severe edema (score 2/4/4), with reactions extending beyond application site

- 48 h: moderate erythema (score 3/3/3) and slight edema (score 2/2/2), with reactions extending beyond application site

- 72 h: well defined or moderate erythema (score 3/3/2) and slight edema (score 2/2/2), with reactions extending beyond application site and desquamation observed in 2 animals

- 7 days: very slight or well defined erythema (score 1/2/1) and very slight edema (score 1/1/1), with reactions extending beyond application site and hyperkeratinization with some flaking of affected areas in all animals

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study the test substance was irritating to the skin of rabbits.

Executive summary:

3 New Zealand white rabbits were dermally exposed to the undiluted test substance (purity: not stated; 0.5 mL fluid were soaked into 6.25 cm² gauze patch) according to testing guideline OECD 404. After 4 h of semiocclusive exposure and at reading times 24, 48 and 72 hours after patch removal the test substance caused well-defined to severe erythema (mean score: 2.89; individual scores per animal: 3/3/2.67) and slight or severe edema (mean score: 2.89; individual scores per animal: 2/3.4/3.4). After 72 h two animals out of three showed desquamation, after 7 days all animals showed hyperkeratinization with some flaking from the affected areas. The test item thus revealed irritating effects.

This study was judged to be reliable with restrictions (RL2), due to the missing substance composition or purity.