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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
Himalayan
Details on test animals or test system 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.