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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:
From 18 December 1996 to 19 June 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
the certificate of analysis is missing from the study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
17 July 1992
Deviations:
yes
Remarks:
temperature and relative humidity occasionally reaching 24°C and 71% respectively. This modification neither affected the course of the study nor its results.
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
29 December 1992
Deviations:
yes
Remarks:
temperature and relative humidity occasionally reaching 24°C and 71% respectively. This modification neither affected the course of the study nor its results.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Pyrrolidine, 1-[2-[2-nitro-4-(phenylmethoxy)phenyl]ethenyl]-
Cas Number:
99474-22-3
Molecular formula:
C19H20N2O3
IUPAC Name:
Pyrrolidine, 1-[2-[2-nitro-4-(phenylmethoxy)phenyl]ethenyl]-
Test material form:
other: solid granular powder
Details on test material:
- Other: beige brown-coloured granular powder
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: B&K Universal G.J., S.L. (Sant Vincenç dels Horts, Barcelona, Spain)
- Age at study initiation: approximately 10-12 weeks
- Weight at study initiation: 2.3-2.4 kg
- Housing: Animals were housed individually in stainless steel cages (48 x 59 x 37 cm) with a grille floor, placed on racks.
- Diet: free access to a standard rabbit diet UAR 112 (Panlab, S.L., Barcelona, Spain. Expiry date: 1997-05-29) which had been analyzed by the manufacturer
- Water: ad libitum by an automatic drinking system. The water was supplied by "Compania de Aguas de Sabadell, S.A." and is periodically checked for the presence of possible contaminants.
- Acclimation period: at least seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 occasionally reaching levels of 24°C
- Humidity (%): 40-70, occasionally reaching levels of 71%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 (7:00 to 19:00)

IN-LIFE DATES: From: 07 January 1997 To: 18 January 1997

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: dampened with water to ensure better contact between the substance and the skin
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
1 hour, 24, 48 and 72 hours after the end of the exposure period.
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Preparation: 24 hours before administration, animals were shaved using an electric razor, leaving the back and sides exposed from scapula to the pelvis.
- Area of exposure: approximately 6 cm2
- Application: the substance was placed on 2.5 x 2.5 cm squares of surgical gauze and applied to the corresponding tests area. The patches were held close to the body using strips of adhesive tape.
- Type of wrap if used:a strip of gauze was wrapped around the trunk of the animal in order to hold the patches in place. The gauze was fixed to the body using additional adhesive tape.

Following administration, animals were observed for a few moments before being returned to their cages.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after the bandage and patches were removed, any remains of the test substance were removed with water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
1 hour, 24, 48 and 72 hours after the end of the exposure period

SCORING SYSTEM: outlined in the OECD guideline n° 404

Erythema and Eschar Formation
No erythema ...................................................................................................................................0
Very slight erythema (barely perceptible) ......................................................................................1
Well defined erythema ....................................................................................................................2
Moderate to severe erythema ........................................................................................................3
Severe erythema (beet redness) to eschar formation preventing grading of erythema ..............4

Oedema Formation
No oedema .........................................................................................................................0
Very slight oedema (barely perceptible)..............................................................................1
Slight oedema (edges of area well defined by definite raising) ........................................2
Moderate oedema (raised approximately 1 mm) ................................................................3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) .........4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: a score of 1 was obtained at the 1h observation time point
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: a score of 1 was obtained at the 1h observation time point
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: a score of 0 was obtained at the 1h observation time point
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: a score of 0 was obtained at the 1h observation time point
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: a score of 0 was obtained at the 1h observation time point
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: a score of 0 was obtained at the 1h observation time point
Irritant / corrosive response data:
- The readings carried out 1 hour after treatment showed very slight erythema (grade 1) in two animals.
- The readings carried out 24, 48 and 72 hours after treatment showed that none of the animals presented any lesions.
- Individual mean scores for erythema and edema, 24, 48 and 72 hours after treatment were all 0.00 for the three animals.
Other effects:
None. The behaviour and physical condition of the rabbits were normal throughout the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions of this study, the test material is not classified as irritating to the skin according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) criteria.
Executive summary:

This GLP-compliant study was performed to assess the potential of the test material to induce skin irritation in vivo, according to OECD Guideline 404 (dated July 17th, 1992) and EU method B.4 of the E.E.C. directive n° 92/69 (dated December 29th, 1992).

Material and methods

0.5 g of the solid test material were applied under semi-occlusive dressing during 4 hours, on a shaved skin area of 3 male rabbits. Skin reactions were recorded 1 hour and then 24, 48 and 72 hours after the end of the exposure period.

Results

1 hour after the patch removal, very slight erythema (grade 1) was observed in two animals. No dermal lesions were observed in any animal at all the other observation time points. The individual mean scores (24, 48 and 72 hours) of all three animals for erythema and edema were both: 0.0, 0.0 and 0.0.

Conclusion

Under the experimental conditions of this study, the test material is not classified as irritating to the skin according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) criteria.

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