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Description of key information

In a skin irritation study with rabbits, performed in accordance with OECD 404 (1992) and according to GLP principles, no signs of irritation were observed.

The QSAR performed on in vivo eye irritation is negative.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 8, 1999 - June 17, 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): PRECYCLEMONE B
- Description: Colourless to pale yellow liquid
- Purity: 99.3%
- Batch No.: 9000320077
- Storage condition of test material: In a refrigerator (2-8°C)
- Expiration date of the batch: March 25, 2000
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: 13 weeks
- Weight at study initiation: Male: 2989 g; Females: 2669 and 2598 g
- Housing: Animals were housed individually in stainless steel cages
- Diet: Free access to pelleted diet for rabbits (Provimi Kliba 3418)
- Water: Free access to tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 – 23
- Humidity (%): 40 - 70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: Adjacent areas of the untreated skin of each animal served as controls
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
1 male and 2 females
Details on study design:
TEST SUBSTANCE PREPARATION
The substance was applied as such.

TEST SITE
Approximately 3 days before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 square centimeters (10x10 cm). The skin of the animals was examined approximately 24 hours before treatment, and, if necessary, regrown fur was again clipped.

APPLICATION
The test substance was applied to approx. 6 square centimeters of the intact skin of the clipped area. It was covered with a 2.5 x 2.5 cm patch of surgical gauze and the gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.

REMOVAL OF TEST SUBSTANCE
Yes, at the end of the exposure period, using lukewarm tap water.

OBSERVATIONS
- Mortality/Viability: Daily
- Toxicity: Daily
- Body Weight: At start of acclimatization, on the day of application and at termination
- Necropsy: Not applicable
- Irritation:
The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance.

SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system according to OECD 404
Irritation parameter:
erythema score
Basis:
animal: #1, #2 and #3
Time point:
other: Mean value of score at 24, 48 and 72h after patch removal
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1, #2 and #3
Time point:
other: Mean value of score at 24, 48 and 72h after patch removal
Score:
0
Max. score:
4
Irritant / corrosive response data:
No signs of irritation were observed.
Other effects:
- All animals had a shiny skin at all readings
- No staining by the test material was observed
- No clinical signs of systemic toxicity were observed
- No mortality occurred
- No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin
- Body weights were within the normal range of variability
Interpretation of results:
GHS criteria not met
Conclusions:
In a skin irritation study with rabbits, performed in accordance with OECD 404 (1992) and according to GLP principles, no signs of irritation were observed.
Executive summary:

In a skin irritation study in rabbits, conducted in accordance with OECD 404 (1992), EU Method B.4 (1992) and according to GLP principles, 1 male and 2 female rabbits were semi-occlusively exposed for 4 hours to 0.5 mL of the substance. No signs of irritation nor clinical signs of toxicity were observed. Based on the results of this study, the substance does not need to be classified for skin irritation/corrosion in accordance with the CLP Regulation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
(Q)SAR
Adequacy of study:
key study
Study period:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
1. SOFTWARE
OECD [Q]SAR Toolbox
2. MODEL (incl. version number)
QSAR Toolbox 3.4.0.17
Database version: 3.8.8/3.1.2
3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL
CAS: 52475-86-2
SMILES: CC(C)=CCCC1CCC(C)(C=O)CC=1
4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
Please see the attached OECD [Q]SAR Toolbox report.
5. APPLICABILITY DOMAIN
The prediction is based on 7 neighbours' values, 5 of them equal to prediction.
Prediction confidence is measured by the p-value = 9.03E-13 (very strong confidence)
6. ADEQUACY OF THE RESULT
Negative for in vivo eye irritation.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Remarks on result:
no indication of irritation
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification