Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The procedures used in the study meet the requirements of the OECD Guideline for Testing of Chemicals No. 404, 1992.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
reaction mass of Lycopyl salt isomers
IUPAC Name:
reaction mass of Lycopyl salt isomers
Details on test material:
- Name of test material (as cited in study report): (2E,4E,6E)-(3,7,11-Trimethyl-dodeca-2,4,6,10-tetraenyl)-triphenyl-phosphonium acetate
- Physical state: clear yellow liquid
- Lot/batch No.: P19-39.5
- Storage condition of test material: In refrigerator at 2-8 °C, protected from light, covered with Nitrogen
- Other: Date of receipt 25 June 1996

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Froxfield Farms (UK) Ltd., Froxfield
- Age at study initiation:
- Weight at study initiation:
- Housing: grid bottomed metal cages
- Diet (e.g. ad libitum): SQC standard rabbit pellets (Special Diet Services, Witham)
- Water (e.g. ad libitum): mains drinking water via automatic drinking system
- Acclimation period: at least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-24
- Humidity (%): 54-82
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: To:

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
aliquot of 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
One hour after removal, similar observations were made after 24, 48 and 72 hours. As the skin reaction resulting from the treatment persisted after 72 hours, additional observations were made after 7 and 14 days.
Number of animals:
one in a pre-test
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm square
- Type of wrap if used: surgical lint


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


SCORING SYSTEM:
no erythema: 0; very slight erythema (barely perceptible): 1; well defined erythema: 2; moderate to severe erythema: 3; severe erythema (beet redness) to slight eschar formation (injuries in depth): 4; no oedema: 0; very slight oedema (barely perceptible): 1; slight oedema (edges of area well defined by definite raising): 2; moderate oedema (raised approximately 1 mm): 3; severe oedema (raised more than 1 mm and extending beyond area of exposure): 4

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #1
Time point:
other: 72 hours
Score:
5.5
Reversibility:
no data

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test article may be seen as a severe irritant to the skin of the albino rabbit under the conditions of the study.
Executive summary:

The purpose of the study was to assessthe degree of irritation produced by the test article, Ro 44 -9567/002, when applied to the intact skin of the albino rabbit. The procedures used meet the requirements of OECD Guideline number 404, adopted 17th July 1992.

In a preliminary test, a 0.5 mL aliquot of the test article was applied over a previously clipped area of the dorsal skin of one albino rabbit. The test article was held in contact with the skin, under semi-occlusive patch assembly, for a 4 hour period. The patch was then removed and the treated site gently cleansed with water. Skin reaction, i.e.erythema and eschar formation as well as oedema, was assessed after one, 24, 48 and 72 hours and 7 and 14 days.

The skin response at the treated site on this animal was apparent within one hour of patch removal and was characterised by well defined erythema and moderate to severe oedema which persistet at the 72 hour examination. At a subsequent examination, made 7 days after dosing, slight erythema and moderate oedema persisted and skin thickening was noted at the treated site. At the final examination, 14 days after dosing, erythema was still apparent although the oedema had subsided. The skin on the treated site was thickened and peeling.

Du to the severity of the skin response in this first rabbit, no further animals were dosed.

The primary irritation index, calculated from the scores obtained from one rabbit, was 5.5.

Accordingly, Ro 44 -9567/002 may be considered as a severe irritant when applied to the skin of the albino rabbit under the conditions of this study.