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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3 - 17 Nov 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
C36 fatty diol
EC Number:
604-608-2
Cas Number:
147853-32-5
Molecular formula:
not available UVCB
IUPAC Name:
C36 fatty diol
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: liquid
- Substance type: UVCB
- Analytical purity: ca. 86%; blend of vegetable esters
- Storage condition of test material: at ambient temperature in the dark
- Specific gravity: 0.9

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: The Broek Institute, Somere, The Netherlands
- Age at study initiation: ca. 13 weeks
- Weight at study initiation: 2393 - 2565 g
- Housing: Animals were individually housed in plastic cages with perforated floors.
- Diet: standard laboratory animal diet (100 g/day, LK-01, diameter 4 mm), obtained from Hope Farms, Worden, The Netherlands
- Water: tap-water, ad libitum via automatic nozzles
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 55 - 75
- 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 sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
14 days
Reading time points: 40 min, 24, 48 and 72 h, 7 and 14 days
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: The test substance was applied to a 6 cm² gauze patch which was attached with a drop of petrolatum to aluminium foil and mounted on permeable tape (Micropore, 3M, St. Paul, USA). This was applied to the dorsal left flank of each animal, the right flank being covered with the same dressing without substance.
- Type of wrap if used: Animals were wrapped in flexible bandage (Coban, 3M, St. Paul, USA).

REMOVAL OF TEST SUBSTANCE
- Washing: After exposure, the remaining test substance was removed, using dry tissue and subsequently a tissue moistened with tap-water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean after 24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean after 24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean after 24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean after 24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean after 24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean after 24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
The test results are shown in Table 1. Forty minutes after test substance removal, the exposed skin showed well-defined erythema and slight swelling in two animals and very slight erythema and edema in the third animal. The erythema varied between very slight and well-defined during the following days and had disappeared on Day 14 in all three animals. The edema persisted until the 72 h observation time in all three rabbits.
Other effects:
No signs of systemic intoxication were observed in any of the rabbits.

Any other information on results incl. tables

Table 1. Results of the skin irritation study.


Observation time Rabbit no.
1 2 3
Erythema Edema Erythema Edema Erythema Edema
40 min 1 1 2 2 2 2
24 h 1 1 1 1 1 1
48 h 1 1 2 1 2 1
72 h 1 1 2 1 1 1
7 days 0 0 1 0 1 0
14 days 0 0 0 0 0 0
Mean value 24 + 48 + 72 h 1.00 1.00 1.67 1.00 1.33 1.00

Applicant's summary and conclusion

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