Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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: guideline study with acceptable restrictions

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

Constituent 1
Reference substance name:
n-undecanal
IUPAC Name:
n-undecanal
Constituent 2
Reference substance name:
2-methyl decanal
IUPAC Name:
2-methyl decanal
Constituent 3
Reference substance name:
n/i-undecanal
IUPAC Name:
n/i-undecanal
Details on test material:
- Name of test material (as cited in study report): n/i-undecanal
- Substance type: colourless
- Physical state: liquid
- Storage condition of test material: room temperature

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

Resultsopen allclose all
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
Irritation parameter:
erythema score
Basis:
mean
Remarks:
: individual scores: 3/3/2.67
Time point:
other: 24-48-72 h
Score:
ca. 2.89
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: reactions were extending beyond the site of application
Irritation parameter:
edema score
Basis:
mean
Remarks:
: individual scores 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

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:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP Regulation
Conclusions:
Under the conditions of this study the test substance was irritating to the skin of rabbits. The proportions of n- and iso-undecanal were not provided, but read across to the registered substance can be made as detailed in the justification provided in the endpoint summary.
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 the test substance caused well-defined to severe erythema (mean score: 2.89) and slight or severe edema (mean score: 2.89). 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 (Ruhrchemie AG/Safepharm, 1985).

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

The proportions of n- or iso-undecanal of the test material was not reported. Read Across is therefore considered. Refer to the discussion field of the endpoint summary for detailed justification of read across.