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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
19. Oct. 2011 - 11. Jan. 2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
The department of health of the government of the United Kingdom

Test material

Constituent 1
Reference substance name:
Fatty acids, C8-18 and C18-unsatd., esters with neopentyl glycol
EC Number:
286-072-6
EC Name:
Fatty acids, C8-18 and C18-unsatd., esters with neopentyl glycol
Cas Number:
85186-86-3
IUPAC Name:
85186-86-3
Details on test material:
- Physical state: yellow liquid
- Analytical purity: 91%
- Lot/batch No.: OE10817
- Expiration date of the lot/batch: 21.102016
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rabbit
Strain:
other: New Zealand White (Hsdlf:NZW)
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12 to 20 weeks
- Weight at study initiation: 2.5 to 2.74 kg
- Housing: individually in suspended cages
- Diet: 2930 Teklad Global Rabbit diet (Harlan Laboratories Ltd., oxon, UK)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, untreated site of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
initial test: 3 minutes, 1 and 4 hours
confirmatory test: 4 hours
Observation period:
7 days
reading time points: 1, 24, 48, 72 hours and 7 days
Number of animals:
3 (1 in the initial , 2 in the confirmatory test)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm on the back of the rabbit
- Type of wrap if used: coton gauze patch secured with a strip of surgical adhesive tape and wrapped in an elastic corset

REMOVAL OF TEST SUBSTANCE
- Washing: gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: end of exposure after 3 minutes, 1 or 4 hours

SCORING SYSTEM: Draize Scoring System

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1 and animal #2
Time point:
other: mean over 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1 and animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Very slight erythema was noted at one treated skin site at the 24 h observation with well-defined erythema and very slight oedema noted at the 48 and 72 h observations. No evidence of skin irritation was noted at two treated skin sites during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DSD: not classified
CLP: not classified

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