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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1988-05-24 to 1988-05-27
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test substance not described in sufficient details. For read-across justification see Section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Witamol 110
- Substance type: product
- Physical state: liquid

- Molecular formula (if other than submission substance): C20 H30 O4
- Molecular weight (if other than submission substance): 334.46
- Smiles notation (if other than submission substance): O=C(c1ccccc1C(=O)OCCCCCC)OCCCCCC

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: approx. 12-16 weeks
- Weight at study initiation: 2.25 - 2.51 kg
- Housing: single housing in suspended metal cages
- Diet (e.g. ad libitum): free access to Rabbit Diet, supplied by Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K.
- Water (e.g. ad libitum): free access to mains drinking water throughout the study
- Acclimation period: minimum of 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 19
- Humidity (%): 68 - 75
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
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:
up to 72 hours
Number of animals:
5 females, 1 male
Details on study design:
TEST SITE
- Area of exposure: clipped skin on the dorsal/flank area, intact epidemis
- % coverage: not mentioned
- Type of wrap if used: On the application area a gauze patch (2.5 cm x 2.5 cm) was placed. The patch was secured in position by a strip of surgical adhesive tape (BLENDERM: approx. size 2.5 cm x 4.0 cm). The trunk of the animals was wrapped in an elasticated corset (TUGRIP)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to Draize J. H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, ¿ The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics¿

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.72
Max. score:
8
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 0.61
- Edema: 0.11
Other effects:
none

Any other information on results incl. tables

Table #: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

60 min

0/0/1/0/0/1

 0/0/0/0/0/0

24 h

 0/0/2/0/1/2

 0/0/1/0/0/1

48 h

 1/1/1/1/1/1

 0/0/0/0/0/0

72 h

 0/0/0/0/0/0

 0/0/0/0/0/0

Average 24h, 48h, 72h

0.61 

 0.11

Reversibility*)

 c.

 c.

Average time (unit) for reversion

 72 hours

 48 hours

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Very slight erythema was noted at two treated skin sites on hour after removal of the patches. Very slight or well-defined erythema, with or without very slight oedema, was noted at three treated skin sites at the 24 h observation. Very slight erythema persisted in all treated skin sites at the 48 h observation. All treated skin sites appeared normal at the 72 h observation.
The test material produced a primary dermal irritation index (PDII) of 0.72 was classified as slightly irritant to rabbit skin.
Executive summary:

The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The study was designed to comply with the requirements of the USA Environmental Protection Agency (EPA).

A single 4 -hour, semi-occluded application of the test material to the skin of six rabbits produced very slight to well-defined erythema with or without very slight oedema. All treated sites appeared normal 72 hours after treatment.

The test material produced a primary dermal irritation index (PDII) of 0.72 and was classified as slightly irritant to rabbit skin.