Sodium 2-[(2-aminoethyl)amino]ethanesulphonate

Endpoint summary

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.