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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994
Reference Type:
other: amendment
Title:
Unnamed
Year:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: USA/EPA/FIFRA guidelines: Subdivision F Series 81
Principles of method if other than guideline:
Evaluation of the cutaneous primary irritation index of the test substance, Laromer PO 33 F, following a single administration (0.5 ml of the test substance in its original form) in rabbits (sacrified and non-sacrified clipped area). The test substance was held in contact with the skin for 24 hrs by means of an occlusive hypoallergenic dressing. Cutaneous reactions were observed approximately 24 and 72 hrs after application of the test substance.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Laromer PO 33 F
- Physical state: liquid, colourless
- Analytical purity: no data available
- Storage condition of test material: room temperature, protected from light

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, Prouzel, France
- Age at study initiation: no data available
- Weight at study initiation: mean body weight of the 6 used animals: 2.5 kg
- Housing: individually
- Diet: free access to 112 C pelleted diet; each batch of food was analysed (composition and contaminants) by the supplier
- Water: filtered by a F.G. Millipore membrane (0.22 micron) and contained in bottles, ad libitum
- Acclimation period: at least 5 days before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Type of coverage:
occlusive
Preparation of test site:
other: scarified and non-scarified
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted
Duration of treatment / exposure:
24 hrs
Observation period:
72 hrs
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: hypoallergenic occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: not mentioned

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24/72 hrs
Score:
3
Max. score:
4
Reversibility:
other: not reversible within 72 hrs
Remarks on result:
other: mean(non-scarified skin)
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24/72 hrs
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 72 hrs
Remarks on result:
other: mean(non-scarified skin)
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24/72 hrs
Score:
2.5
Max. score:
4
Reversibility:
other: not reversible within 72 hrs
Remarks on result:
other: mean(non-scarified skin)
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24/72 hrs
Score:
2.5
Max. score:
4
Reversibility:
other: not reversible within 72 hrs
Remarks on result:
other: mean(non-scarified skin)
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24/72 hrs
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hrs
Remarks on result:
other: mean(non-scarified skin)
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24/72 hrs
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hrs
Remarks on result:
other: mean(non-scarified skin)
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24/72 hrs
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hrs
Remarks on result:
other: mean(non-scarified skin)
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24/72 hrs
Score:
0
Max. score:
4
Reversibility:
other: no effect
Remarks on result:
other: mean(non-scarified skin)
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24/72 hrs
Score:
0
Max. score:
4
Reversibility:
other: no effect
Remarks on result:
other: mean(non-scarified skin)
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24/72 hrs
Score:
0
Max. score:
4
Reversibility:
other: no effect
Remarks on result:
other: mean(non-scarified skin)
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24/72 hrs
Score:
0
Max. score:
4
Reversibility:
other: no effect
Remarks on result:
other: mean(non-scarified skin)
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24/72 hrs
Score:
0
Max. score:
4
Reversibility:
other: no effect
Remarks on result:
other: mean(non-scarified skin)
Irritant / corrosive response data:
Slight to marked erythema (scores 1 to 3) was observed on all animals 24 hrs after application of the test substance. Erythema (scores 1 to 3) persisted on 5 animals at the 72 hrs reading. Severe edema (score 4) was noted on 1 animal (animal 1) 24 hrs after application of the test substance. Dryness of the skin was observed on 2 animals (animal 1 and 4) at the 72 hrs reading.

Any other information on results incl. tables

The Cutanous Primary Irritation Index was calculated to be 2.0. According to the authors, the test substance Laromer PO 33 F, was considered slightly irritant when administered by the cutaneous route in rabbits.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information