Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

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 Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries. 12 Nousan, Notification No. 8147, November 2000, including the most recent partial revisions.
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MTDID 7145
- Molecular weight (if other than submission substance): 399
- Substance type: Clear colorless liquid
- Physical state: liquid
- Analytical purity: ~94.5%
- Lot/batch no.: Batch 142072:43
- Expiration date of the lot/batch: 30 December 2007
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
- Other: Test substance is volatile. pH: 7.2. Specific gravity: 1.8

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- sex : Male
- Source: Harlan, Horst, The Netherlands
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1.0 kg
- Housing:- Diet (e.g. ad libitum): ~100 g/day pelleted diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 21 C
- Humidity (%): 43-69%
- Air changes (per hr): Approximately 15
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): applied undiluted
Duration of treatment / exposure:
4 hours
Observation period:
1, 24,48 and 72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 150 square centimeters
- % coverage: 2x3 cm Metalline patch mounted on Micropore tape wrapped around abdomen and secured with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 4 hours after application
SCORING SYSTEM: 0-4 erythema and eschar formation; 0-4 edema formation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of skin irritation, corrosion, skin coloring or toxicity was observed. Scores of 0 were noted at all timepoints.

Any other information on results incl. tables

No signs of skin irritation, corrosion, skin coloring or toxicity was observed. Scores of 0 were noted at all timepoints.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: OECD GHS and EU
Conclusions:
No skin irritation was caused by 4 hours exposure to the test article.
Executive summary:

A primary skin/irritation study was performed with the test article according to OECD Study Guideline No. 404 (2002). Three New Zealand albino rabbits (male) were exposed to 0.5 ml (undiluted) of the test article by application onto clipped skin using a semi-occlusive dressing. The exposure periods were 3 minutes, 1 hour and 4 hours, respectively. Skin reactions were assessed at least once daily for 4 days after treatment. No skin irritation of any kind was caused by up to 4 hours of exposure to the test article. Neither, was there any lethality or any indication of systemic toxicity during testing period. Based on these results test article does not have to be classified and has no obligatory labeling requirement of skin irritation according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) and EC criteria for classification and labelling.