Registration Dossier

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:
2017-06-01 to 2017-07-2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
28 July 2015
GLP compliance:
yes (incl. certificate)
Remarks:
Bayrisches Landesamt für Gesundheit und Lebensmittelsicherheit

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: 20-21 weeks
- Weight at study initiation: > 3.9 kg
- Housing: ABS-plastic or Noryl rabbit cages; not reported how many animals housed per cage
- Diet: Altromin 2123 maintenance diet for rabbits provided ad libitum
- Water: Municipal drinking water provided ad libitum
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3
- Humidity (%): 55±10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light):12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
In an initial test, one animal was exposed to the test material for 3 minutes, 1 hour, and 4 hours without any reactions being observed. For the experiment, the second animal was exposed to the test material for 4 hours.
Observation period:
72 hours initially; the observation period was extended for animal no. 1 to 6 days and 5 days for animal no. 2 in order to evaluate the reversibility of lesions
Number of animals:
2 males
Details on study design:
TEST SITE
- Area of exposure: Dorsal area of the trunk (6 cm2)

- Type of wrap if used: treatment area covered with gauze patch and held in place with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: Test material was removed by using cottonseed oil for animal no. 1; there was no residual test material to be removed from animal no. 2.
- Time after start of exposure: at the end of the exposure period for animal no. 1

OBSERVATION TIME POINTS
0 hr, 1 hr, 24 hr, 48 hr, 72 hr, day 4, day 5, day 6

SCORING SYSTEM:
Erythema and eschar formation: no erythema = 0; very slight erythema = 1; well defined erythema = 2; moderate to severe erythema = 3; severe erythema to eschar formation preventing grading of erythema = 4
Edema formation: no edema = 0; very slight edema = 1; slight edema = 2; moderate edema = 3; severe edema = 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Other effects:
There were no significant effects on body weight.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification is required according to Regulations (EC) No 1272/2008.
Conclusions:
In an in vivo skin irritation study according to OECD guideline 404 and in compliance with GLP, the mean (24-72 hours) erythema score observed in 2 animals was 1; the mean (24-72 hours) edema score for the same animals was 0. All irritation was reversible within 6 days. Therefore, the test item should not be classified as an irritant.