Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

A Corrositex test with the test substance resulted in mild corrosivity with a breakthrough time of 109 min (Tao, 2013) and is classified in Skin corrosion Cat 1C.

As no data available concerning eye irritation the test substance is classified in Serious Eye damage Cat 1.

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:
weight of evidence
Study period:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Corrositex test - guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Deviations:
no
GLP compliance:
yes
Duration of treatment / exposure:
time of the change for the replicates (min) 105.50 113.67 103.00 114.50
Irritation / corrosion parameter:
penetration time (in minutes)
Value:
> 103 - < 114.5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other:
Remarks:
Basis: other: membrane break through. Time point: 109.2. Reversibility: other: not applicable. Remarks: Corrositex test observed breakthrough time of 109 minutes (standard deviation 5.78 ). Category I material resulting in a packaging group III corrosive rating.. (migrated information)
Conclusions:
A Corrositex test with Formaldehyde, polymer with benzenamine, hydrogenated resulted in mild corrosivity with a breakthrough time of 109 min. Category 1C corrosive.
Executive summary:

A Corrositex test with Formaldehyde, polymer with benzenamine, hydrogenated resulted in mild corrosivity with a breakthrough time of 109 min. Category 1C corrosive.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Formaldehyde, polymer with benzenamine, hydrogenated was corrosive in an in vitro Corrositex test. Signs of irritation/corrosivity were also observed in the acute oral and dermal toxicity tests with this material and in tests with similar substances.


Justification for classification or non-classification

Based on the in vitro Corrositex test and according to the Globally Harmonized Classification System (GHS) the test item is classified in the hazard category Skin Corr. 1C, required labelling with 'Danger' and 'Causes severe skin burns and eye damage'. According to the EC Regulation 1272/2008 and subsequent regulations, the test item required labelling with 'Danger' and 'H314: Causes severe skin burns and eye damage'.

Regarding effects on eyes, the test substance is classified in the hazard category Eye Damage 1, required labelling with 'H318: Causes serious eye damage'.