Ferrate(1-), bis[4-[2-[5-chloro-2-(hydroxy-.kappa.O)phenyl]diazenyl-.kappa.N1]-3-(hydroxy-.kappa.O)-N-phenyl-2-naphthalenecarboxamidato(2-)]-, ammonium (1:1)

Endpoint summary

Description of key information

Skin irritation (in vivo): Not irritating (OECD 404)

Serious eye damage/eye irritation (in vivo): Not irritating (OECD 405)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

other: SNIF

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

All information in this endpoint has been provided by the ECHA using the 12-year rule, this is data not owned by the registrant. The reliability is assumed to be at level 2. Therefore the following reliability statement can be used: Study conducted in accordance with generally accepted scientific principles, possibly with incorect reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Vehicle:

other: Moistened with 0.5 ml distilled water.

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hrs

Number of animals:

3 rabbits

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Other effects:

No skin reactions were seen.

.

Interpretation of results:

GHS criteria not met

Conclusions:

In a dermal irritation study in rabbits, the substance is not irritating.

Executive summary:

In a primary dermal irritation study (OECD 404), 3 New Zealand white rabbits were dermally exposed (occlusive) to 0.5g of DL-N33 in distilled water for 4 hours.

The mean erythema and odema scores at 24, 48 and 72 hr timepoints were 0; no skin reactions were seen.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

other: SNIF

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

All information in this endpoint has been provided by the ECHA using the 12-year rule, this is data not owned by the registrant. The reliability is assumed to be at level 2. Therefore the following reliability statement can be used: Study conducted in accordance with generally accepted scientific principles, possibly with incorect reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Vehicle:

not specified

Amount / concentration applied:

30mg (0.1ml)

Duration of treatment / exposure:

Not specified

Number of animals or in vitro replicates:

3 rabbits

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

Slight conjunctival irritation was observed in all three animals at the one-hour reading only. This was completely resolved by Day 2. No corneal damage or iridial inflammation were observed in any of the animals.

Interpretation of results:

GHS criteria not met

Conclusions:

In an in vivo eye irritation study in rabbits, the substance was not irritating.

Executive summary:

In a primary eye irritation study (Annex V), 30mg of DL-N33 was instilled into the eye of 3 New Zealand white rabbits.

Slight conjunctival irritation was observed in all three animals at the one-hour reading only. This was completely resolved by Day 2. No corneal damage or iridial inflammation were observed in any of the animals. Cornea opacity, iris, conjunctivae and chemosis scores at 24, 48 and 72 hrs were 0.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

There are no in vitro skin irritation/corrosion studies available. There is one in vivo study in rabbits available.

In a primary dermal irritation study (OECD 404), 3 New Zealand white rabbits were dermally exposed (occlusive) to 0.5g of DL-N33 in distilled water for 4 hours. The mean erythema and odema scores at 24, 48 and 72 hr timepoints were 0; no skin reactions were seen.

Eye irritation

There is no in vitro eye irritation studies available. There is one in vivo study in rabbits available.

In a primary eye irritation study (OECD 405), 30mg of DL-N33 was instilled into the eye of 3 New Zealand white rabbits. Slight conjunctival irritation was observed in all three animals at the one-hour reading only. This was completely resolved by Day 2. No corneal damage or iridial inflammation were observed in any of the animals. Cornea opacity, iris, conjunctivae and chemosis scores at 24, 48 and 72 hrs were 0.

The studies are suitable to use in the human health risk assessment.

Justification for classification or non-classification

Based on the available information in the dossier, the substance DL-N33 (CAS No. 104815-18-1) is not classified for skin irritation/corrosion or serious eye damage/eye irritation when considering the criteria outlined in Annex I of 1272/2008/EC.