Registration Dossier

Administrative data

Description of key information

Tetrakis(hydroxymethyl) phosphonium chloride, oligomeric reaction products with urea is considered to be corrosive to skin and eyes.

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: Guideline study (GLP)
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
other: OECD 402, EC B.3, OPPTS 870.1200
Deviations:
no
Remarks:
24 hours exposure
GLP compliance:
yes (incl. certificate)
Species:
rat
Strain:
Wistar
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
2000 mg/kg bw
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
5m, 5fm
Irritation parameter:
other: scar formation
Basis:
animal #3
Time point:
other: day 9 post exposure
Score:
1
Max. score:
1
Reversibility:
not reversible
Remarks on result:
other: female rats
Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
2000 mg/kg bw of Aflammit SAP is corrosive to skin after 24 hours exposure. Scar formation becomes visible at day 9 post application.
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

The test substance has very low vapor pressure and no significant inhalation exposure is expected. The substance is an salt and manufactured and marketed in form of an aqueous solution. The use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and no inhalation test or airway irritation test was performed. No respiratory irritation did occur under intended conditions of handling and use (contiunous observation at workplaces in manufacturing site as well as in textile treatment plant).


Justification for selection of skin irritation / corrosion endpoint:
A acute dermal toxity test (OECD 402, GLP) was performed on the substance (test item AFLAMMIT SAP) using Wistar rats.The test item was applied in one dose (2000 mg/kg bw) for 24 hours followed by a 14 day observation period. No mortalities occured in male and female rats (5 per sex)): LD50 > 2000 mg/kg bw. Symptoms in the skin were observed only in female rats and were reversible after 11 day with the exeption of one female rat, which showed necrosis and scar on the treated skin at necropsy. Pinprick-size haemorrhages were observed in 3 of male and 3 of 5 female rats by necropsy after 14 days. Conclusion: 2000 mg/kg bw of Aflammit SAP is corrosive to skin after 24 hours exposure. Scar formation becomes visible at day 9 post application.
The skin corrosive potential of Aflammit SAP was assessmed (Thor report No. CO lVT-l0-083) in vitro using the EpiDerm™ reconstructed Human Epidermis (EU B.40, GLP). A cytotoxic response is obvious but not conclusively for classification according to criteria of the test. In view of the evidence from two in vivo tests this result is considered not relevant for the endpoint skin corrosion.
WoE: Peer reviewed citation of a guideline study without details. A single 4-hour, semioccluded application of the substance to intact rabbit skin (OECD 404, GLP) caused corrosion in 2/6 animals and very slight to well defined erythema and very slight to slight edema in 4/6 treated animals. The test is perfomed with the same substance but another product name. Evaluated data from a reliable secondary source (US-CPSC).

There is enough evidence from exisiting data to conclude that the substance can be corrosive to skin. The data are sufficient and a classifiction as corrosive to skin is necessary and no further testing is required. Exposure with treated textile articles were found non-irritating to skin. The chemical fixation of the durable textile finish converts the substance into inert polymer.

Justification for selection of eye irritation endpoint:
The substance was found to be corrosive to skin. Therefore, irriversible damage to eyes can be expected. (Test waived)

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Tetrakis(hydroxymethyl) phosphonium chloride, oligomeric reaction products with urea is considered to be cytotoxic by its intrinsic chemical reactivity. The IVT skin corrosion test (Gray 2011 OECD 431) with Aflammit SAP is negative, but in vivo data (Pascic 2006 OECD 402; Snell 1994b OECD 404) are sufficiently conclusive for classification as corrosive.

Skin Corr 1B, H314; (Eye damage 1 H318)