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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01 Mar 1988 - 22 Mar 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
adopted September, 1984
Deviations:
no
GLP compliance:
yes
Remarks:
.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Pripol 1009/Dimer acid
- Physical state: liquid
- Analytical purity: approximately 99 %
- Storage condition of test material: at ambient temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 2046, 2240 and 2101g
- Housing: individually
- Diet (e.g. ad libitum): standard laboratory animal diet LKK-20 and LK-04 (100g/day)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated sites 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:
4 hours
Observation period:
21 days. Reading time points: 1, 24, 48, 72 h and 7, 14, 21 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6cm²
- Type of wrap if used: permeable tape (Micropore, 3M, St. Paul, USA)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, dry tissue und subsequently a tissue moistened with tap-water
- Time after start of exposure: 4h

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48, 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal: #1, 2, 3
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Test article caused well-defined erythema in one animal and very slight erythema in the two other animals, 1 hour after test substance removal. The erythema noted in one animal increased temporarily to well-defined by the next day and thereafter very slight erythema persisted to day 7. The well-defined erythema decreased to very slight within 24 hours and persisted thereafter to day 14. A further animal showed very slight erythema during the first week of observation. No edema was observed in any of the animals. The treated skin of all three rabbits showed some scaliness when examined on days 7 and 14. Scaliness was no longer observed on day 21.
Other effects:
No signs of systemic intoxication were observed in any of the rabbits.

Any other information on results incl. tables

The authors stated that, based on these results, the test substance should be considered as slightly irritating to the skin. However, applying the current DSD and CLP criteria for classification and labelling of dangerous substances, the test substance need not be labelled as a skin irritant.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance does not fulfil the requirements to be classified according to DSD and CLP criteria for classification and labelling.
DSD: no classification
CLP: no classification