Reaction products of N-(2-aminoethyl)ethane-1,2-diamine and methyl methacrylate and octane-1-thiol

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Performed to GLP following methods current in 2014 Validity criteria met.

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

GLP compliance:

yes (incl. QA statement)

Irritation / corrosion parameter:

other: other: Relative mean tissue viability

Value:

ca. 93

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 15 minutes exposure, 42 hour observation. (migrated information)

Irritant / corrosive response data:

Exposure period 15 minutes, followed by 42 hour observation; no adverse effect in relation to control
Three replicates - viability range 81.3 % - 99.7%

Other effects:

No other effects reported

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The results suggest no significant irritancy to skin through direct tissue effects by in-vitro assessment.
This does not necessarily preclude minor dermal effects on live skin, such as mild discomfort and redness (erythema)

Executive summary:

The results suggest that the test substance does not need classification as irritating to skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Performed to recognised methods 2014

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

GLP compliance:

yes (incl. QA statement)

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.75 ml undiluted test material

Duration of treatment / exposure:

10 minute exposure

Observation period (in vivo):

120 minute observation, incubated at 32 C

Irritation parameter:

cornea opacity score

Basis:

other:

Score:

82.4

Reversibility:

other: not applicable

Irritant / corrosive response data:

A corneal score of 82.4 was assigned

The corneas treated with the test item were clear post treatment and cloudy post incubation. The corneas treated with the negative control item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation.

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The results of this study have identified the test item as Category 1. UN GHS or EU CLP
Causes serious eye damage.

Executive summary:

The results of this study have identified the test item as Category 1. UN GHS or EU CLP Causes serious eye damage.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Justification for selection of skin irritation / corrosion endpoint:
In-vitro assays for skin irritation and skin corrosivity showed mimimal effects and classification as irritating to skin is not required.

Justification for selection of eye irritation endpoint:
Only one study performed.
The results of this study have identified the test item as Category 1. UN GHS or EU CLP
Causes serious eye damage.

Effects on eye irritation: highly irritating