Registration Dossier

Administrative data

Description of key information

There no data available on -phosphonic ester residue with respect to irritating effects on skin and mucous membranes (eyes). 
There is one component which is evaluated as corrosive and classified with R35 = causes severe burns. Its content in the mixture is about 30 %.. Therefore, there is no need to conduct a studies on skin irritation/corrosion or eye irritation with phosphonic ester residue because the available information indicates that the criteria are met for classification phosphonic ester residue as corrosive

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:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: secondary citation in a peer Review based on a guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
no data
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
physiological saline
Controls:
not specified
Amount / concentration applied:
500 mg/patch
Duration of treatment / exposure:
3 min and 4 hours
Observation period:
according to guideline: no details given
Number of animals:
according to guideline: no details given
Details on study design:
according to the respective guideline
Irritation parameter:
other: the sloggy test substance was evaluated corrosive
Basis:
other: the sloggy testsubstance was evaluated corrosive
Time point:
other: 3 min or 4 hours, respectively
Reversibility:
other: the sloggy testsubstance was evaluated corrosive
Remarks on result:
other: no details given
Irritant / corrosive response data:
the test substance was evaluated corrosive
Interpretation of results:
Category 1A (corrosive) based on GHS criteria
Conclusions:
Classification: highly corrosive (causes severe burns)
Executive summary:

Phosphonic acid is tested for skin irritation according to OECD TG 403 and revealed to be corrosive.

ECB (2000):

SO-Freetext: Hoechst AG  Frankfurt/Main
Hoechst AG  Frankfurt/Main
Clariant GmbH  Frankfurt am Main:

Only the sloggy product was corrosive to the skin

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Additional information

There no data available on -phosphonic ester residue with respect to irritating effects on skin and mucous membranes (eyes).

Phosphonic ester residue contains monomethyl phosphonate, phosphonic acid, and Dimethylphosphonate, salt of pyrophosphoric acid. and phosphate which were not further specified

SKIN IRRITATION / CORROSION

Monomethylphosphonate

750 µg of the test substance was applied to the skin of rabbits for 24 hours. The substance caused severe irritation effects (Marhold 1986)

Phosphonic acid

Phosphonic acid is tested for skin irritation according to OECD TG 404 and revealed to be corrosive. According to 67/548 EEC the compound is labelled with R35 = causes severe burns.

Dimethylphosphonate

In a limited study for skin irritation dimethylphosphonate was applied to the inner surface of an ear of rabbits for 4 hours and after washing observed for further 7 days.On the basis of the results of this study it can be concluded that dimethyl phosphionate is not a skin irritant. Futhermore, the prolongation of the exposure period up to 8 hours did not show relevant irritation effects of the test item on the skin All together the above described results show that dimethyl phophonate is not a skin irritant

Salt of pyrophosphoric acid and phosphate(not further specified)

There are no data available

OVERALL EVALUATION OF SKIN IRRITATION / CORROSION

There are no data on skin irritation property of the residue. However, there is one component which is evaluated as corrosive and classified legally with R35 = causes severe burns. Its content in the mixture is about 30 %.. According to Regulation (EC) 1972/2008 GHS/CLP section 3.2.3.3.6. a mixture containing a corrosive ingriedient with more than 5 %, this mixture has to be evaluated as corrosive to the skin. Thus, according to Regulation (EC) 1907/2006 (REACh) ANNEX VII section 8.1 column 2 there is no need to conduct a studies on skin irritation/corrosion with phosphonic ester residue because the available information indicates that the criteria are met for classification phosphonic ester residue as corrosive to the skin

EYE IRRITATION / CORROSION

Monomethylphosphonate

no data on eye irritation/corrosion available

Phosphonic acid

There are no data on eye irritation/corrosion: the substance is classified/labelled with R35 = causes severe burns

Dimethylphosphonate

For eye irritation one reliable study exists using a method similar to OECD guideline 405 with deviations (No GLP study, only 2 animals were used,. no information about environmental and housing conditions). Animals were observed for 7 days. Irritation was scored according to the method of Draize. Reddening of the conjunctiva (grade 2) was observed 1h after treatment; no other effects were observed. Effects were reversible within 5 days. Based on the data available, it can be concluded that dimethyl phosphonate is not irritating to eyes.

Salt ofpyrophosphoric acid and phosphate (not further spedified)

no data available on eye irritatio/corrosion

OVERALL EVALUATION ON EYE IRRITATION

There are no data available evaluating the irritating effect on mucous membranes. . According to Regulation (EC) 1907/2006 ANNEX VII section 8.2..column 2 there is no need to conduct a sudy because the available information indicates that the criteria are met for classification as corrosive to the skin.


Justification for selection of skin irritation / corrosion endpoint:
There are no data on skin irritation property of the residue. However, there is one component(Phosphoric acid) which is evaluated as corrosive and classified with R35 = causes severe burns. Its content in the mixture is 30 %.. According to Regulation (EC) 1972/2008 GHS/CLP section 3.2.3.3.6. a mixture containing an ingriedient with more than 5 % this mixture has to be evaluated as corrosive to the skin. Thus, according to Regulation (EC) 1907/2006 (REACh) ANNEX VIII section 8.1 column 2 there is no need to conduct further studies on skin irritation/corrosion because the substance is classified as corrosive.

Justification for selection of eye irritation endpoint:
There are no data with phosphonicester residue available evaluating the irritating effect on mucous membranes. According to Regulation (EC) 1907/2006 ANNEX VII section 8.2..column 2 there is no need to conduct a sudy because the critera are met for classification phosphonicester residue as corrosive to the skin.

Effects on skin irritation/corrosion: corrosive

Justification for classification or non-classification

According to Regulation (EC) 1972/2008 GHS/CLP section 3.2.3.3.6. a mixture containing a corrosive ingriedient with more than 5 %, this mixture has to be evaluated as corrosive to the skin and to be classified and labelled accordingly