Registration Dossier

Administrative data

Description of key information

The substance (about 50% in water) should be regarded as non irritating to the skin of rabbits. 
Two in vitro studies (Human Corneal Epithelial Cell model - HCE; Hen's Egg Test - Chorioallanoic Membrane Test, HET-CAM), alternatives to the Draize rabbit eye irritation test, are available which indicate a strong eye irritation potential of the substance (about 50% in water).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Reason / purpose:
reference to other study
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)
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG, Branch Lohndorf, 24601 Lohndorf/Post Wankendorf, Germany
- Age at study initiation: 4 - 5 months
- sex: males
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral untreated skin area of test animals served as control
Amount / concentration applied:
Amount: 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hours,  and 4 to 14 days after application
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: non irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: treated skin area carefully washed with water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
overall irritation score
Basis:
animal: #2 and #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Other effects:
There were no systemic intolerance reactions.
Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:




Classification: not irritating
Executive summary:

In a study performed according to OECD 404 the test item was shown to be slightly irritating to the skin of rabbits. No systemic intolerance reactions were observed.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Based on the available information AAS-solution is not irritating to the skin of rabbits and should be considered as highly irritating to the eyes. There are no data gaps for the endpoint irritation/corrosion. There is no reason to believe that these results would not be applicable to humans.


Justification for selection of skin irritation / corrosion endpoint:
Data in line with in vitro results; only one in vivo study available

Justification for selection of eye irritation endpoint:
No study was selected since both in vitro studies indicate a strong eye irritation potential and thus, no in vivo study was performed.

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Based on the available data and according to Regulation (EC) 1272/2008 the substance is not classified for skin irritation.

According to Regulation (EC) 1272/2008 the substance is classified with Eye Damage 1, based on the results of two independent in vitro tests, i.e. alternatives to the Draize rabbit eye irritation test.