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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

- Skin irritation: THPC-urea is considered as corrosive and classified into category 1C, H314.

- Eye irritation: Based on the corosivity of THPC urea, a waiving was proposed

- Respiratory irritation: No study available.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

1- Skin irritation/ corrosion:

One study was available for this endpoint and considered as the key study (SPL, 1994). This study was conducted according to OECD guideline 404 and in compliance with GLP (Kr: 1). Six New Zealand White rabbits were exposed to 0.5 mL of a water dilution of THPC-urea (around 65% Active Ingredient – AI). Test sites were covered with a semi-occlusive dressing for 4 hours. Changes were observed at 1,24, 48 and 72 hours as well as 7, 10 and 14 days after removal of the dressing (at day-7, traces of remaining product found on the fur of all rabbit). Mean score (24, 48 and 72 hours) were 2.2 for erythema/eschar and 1.7 for oedema. These effects were not reversible. Scar tissue and small superficial scattered scabs were noted in one female (mean score were 4 for erythema and 2 for oedema) at the 14 -day observation. Scar tissue reduced re-growth of fur, glossy skin and small superficial scattered scabs were observed in one male (mean score were 4 for erythema and 2.3 for oedema) at the 14 -day observation. Based on these results, THPC-urea is considered as corrosive.

2- Eye irritation/ corrosion:

No study is available for this end-point. However, the study is scientifically unjustified considering animal welfare as THPC-urea

was classified as skin corrosive (column 2 of REACH Annex VIII). Based on the results of the skin irritation study (SPL, 1994),

THPC-urea is classified as "causes severe skin burns and eye damage" according to EU criteria.

Justification for selection of skin irritation / corrosion endpoint:
Only one study was available.

Justification for selection of eye irritation endpoint:
In accordance with column 2 of REACh Annex VIII, the in vivo eye irritation study (required in section 8.2.1) do not need to be conducted as the substance is classified as corrosive to the skin based on the results of the skin irritation study (SPL, 1994).

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Skin/ Eye corrosion:

After 4h of dermal exposure of rabbit skin to THPC-urea (with traces of test material until day 7 on skin of all animals), small areas of necrosis and small superficial scattered scrabs were noted, with absence of recovery up to 14 days of observation (SPL 1994, Kr:1). Therefore, THPC-urea should be classified in category1C, H314 (causes severe skin burns and eye damage) according to the CLP regulation (1272/2008) and as corrosive (C, R34) according to the Directive 67/548/EEC.