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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 mins - 42 hours
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Guideline study to GLP, 2017
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Lot number HMK/370/12/1
Storage conditions Room temperature (15 – 25°C)
Purity/Assay Active >98%
Appearance Straw to Yellow Clear Bright Liquid
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
10 μL undiluted liquid
Duration of treatment / exposure:
15 minutes exposure
Duration of post-treatment incubation (if applicable):
42 hours followed by MTT exposure of 3 hours.
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1
Value:
> 9.2 - < 10.6
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
Positive control was in the range of 8.2 - 14.3 and considered valid.
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Considered irritting to the 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:
guideline study
Justification for type of information:
Guideline study to GLP, 2017
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Lot number: HMK/370/12/1
Storage conditions: Room temperature (15 – 25°C)
Purity/Assay: Active >98%
Appearance: Straw to Yellow Clear Bright Liquid
Species:
cattle
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
750 μL
Irritation parameter:
in vitro irritation score
Run / experiment:
1
Value:
ca. 20.6
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
The positive control, ethanol, elicited an In Vitro Irritancy Score of 40.2.
The negative control, 0.9% sodium chloride solution, opacity mean change value was 1.7
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Although the result concludes that the irritancy cannot be predicted, the substance caused a degree of corneal opacity with a score of ca 20 and significantly over the limit score of 3 for non-classified.
In view of this indication of some eye irritation, classification as Eye Irrit 2 is proposed.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The results of the in vitro tests performed with formaldehyde, reaction products with ethylendiamine show neither corrosive nor irritation properties related to the test item. The ex vivo study performed to evaluate the irritation potential of the tet substance to the eyes, showed a moderate irritating potential.

Justification for selection of skin irritation / corrosion endpoint:

As in the skin corrosion study formaldehyde, reaction products with ethylendiamine resulted non corrosive, a skin irritation study has been carried out. Also this study gave negative results and therefore it has been choosen as endpoint selection study.

Effects on eye irritation: moderately irritating

Justification for classification or non-classification

According to the results of the available studies, formaldehyde, reaction products with ethylendiamine is classified as follows, according to Regulation 1272/2008/EC:

Eye Irrit. 2, H319.