Ferrate(2-), [[N,N'-1,2-ethanediylbis[N-[(carboxy-.kappa.O)methyl]glycinato-.kappa.N,.kappa.O]](4-)]-, (OC-6-21)-

Endpoint summary

Description of key information

- Skin irritation: not irritating by analogy with FeNaEDTA (CAS 15708-41-5)
- Eye irritation: not irritating by analogy with FeNaEDTA (CAS 15708-41-5)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

July 2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well conducted study according to GLP (as the data is used in a read-across approach, a maximal reliability score of 2 was attributed).

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: LPT, 24601 Löhndorf, germany
- Age at study initiation: 3-5 months
- Weight at study initiation: 1.8 - 2.3 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 60 per hour
- Photoperiod (hrs dark / hrs light):12/12


IN-LIFE DATES: From: 2. To: 6.July 2007

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg/animal

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- % coverage:
- Type of wrap if used: gauze patch


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

Irritation parameter:

erythema score

Basis:

animal: one animal

Time point:

other: 1 hour

Score:

1

Reversibility:

fully reversible

Irritant / corrosive response data:

Very slight erythema (grade 1) was observed in one animal at 1 h after removal of the patch. There were no further skin reactions and no systemic adverse effects.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The test iterm is not irritating to the skin.

Executive summary:

In a skin irritation study according to OECD guideline 404 a dose of 500 mg FeNaEDTA was applied to the shaved skin of three male rabbits for 4 hours. Very slight erythema was noted for one animal at 1 hour after patch removal. No other skin effects or systemic effects were noted during the observation period of 72h.

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:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

July 2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well conducted study according to GLP (as the data is used in a read-across approach, a maximal reliability score of 2 was attributed).

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: LPT germany
- Age at study initiation: 4-5 months
- Weight at study initiation: 2.2-2.4
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3°C
- Humidity (%): 30-70%
- Air changes (per hr): 60
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 4. To: 12.July 2007

Vehicle:

unchanged (no vehicle)

Irritant / corrosive response data:

Under the present test conditions a single administration of 100 mg FeNaEDTA per animal into the conjunctival sac of the right eye of three rabbits caused the following effects:
Corneal opacity (grad 1) was observed in animal no. three 24 hours to 6 days after instillation.
The fluorescein test performed 24 hours after instillation revealed corneal staining in animal no. 3 (up to 1/4 of the surface).
Conjunctival redness (grad 1) was observed in animal no. one 60 minutes, in animal no. two 60 minutes to 48 hours and in animal no. three 24 hours to 4 days after instillation.
In addition, secretion was observed in all 3 animals 1 hour after instillation.
The irises were not affected by instillation of the test item.
There were no systemic intolerance reactions.

Time after administration	C O R N E A	I R I S	C O N J U N C T I V A E	C H E M O S I S
	Opacity		Redness
	A n i m a l  n o. : 1 / 2 / 3
before dosing	0/0/0	0/0/0	0/0/0	0/0/0
60 minutes	0/0/0	0/0/0	1/1/0	0/0/0
24 hours	0/0/1	0/0/0	0/1/1	0/0/0
48 hours	0/0/1	0/0/0	0/1/1	0/0/0
72 hours	0/0/1	0/0/0	0/0/1	0/0/0
4 days	-/-/1	-/-/0	-/-/1	-/-/0
5 days	-/-/1	-/-/0	-/-/0	-/-/0
6 days	-/-/1	-/-/0	-/-/0	-/-/0
7 days	-/-/0	-/-/0	-/-/0	-/-/0

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Although the test item induced slight irritation, no classification is needed according to OECD-GHS.

Executive summary:

An eye irritation study with three male Himalyan rabbits according to OECD guideline 405 and GLP was performed.

A single administration of 100 mg FeNaEDTA per animal into the conjunctival sac of the right eye of three rabbits caused the following effects:

Corneal opacity (grade 1) was observed in animal no. three 24 hours to 6 days after instillation.

The fluorescein test performed 24 hours after instillation revealed corneal staining in animal no. 3 (up to 1/4 of the surface).

Conjunctival redness(grade 1) was observed in animal no. one 60 minutes, in animal no. two 60 minutes to 48 hours and in animal no. three 24 hours to 4 days after instillation. In addition, secretion was observed in all 3 animals 1 hour after instillation.

Irises were not affected by instillation of the test item.

There were no systemic intolerance reactions.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

There is no data available on the test item, but the skin irritation and eye irritation potential of EDTAFeHNa was assessed by analogy with FeNaEDTA (CAS 15708-41-5):

In a skin irritation study according to OECD guideline 404 a dose of 500 mg FeNaEDTA (CAS 15708-41-5) was applied to the shaved skin of three male rabbits for 4 hours. Very slight erythema was noted for one animal at 1 hour after patch removal. No other skin effects or systemic effects werenoted during the observation period of 72h.

An eye irritation study with three male Himalyan rabbits according to OECD guideline 405 and GLP was performed. A single administration of 100 mg FeNaEDTA per animal into the conjunctival sac of the right eye of three rabbits caused the following effects:

Corneal opacity (grade 1) was observed in animal no. three 24 hours to 6 days after instillation.

The fluorescein test performed 24 hours after instillation revealed corneal staining in animal no. 3 (up to 1/4 of the surface).

Conjunctival redness (grade 1) was observed in animal no. one 60 minutes, in animal no. two 60 minutes to 48 hours and in animal no. three 24 hours to 4 days after instillation. In addition, secretion was observed in all 3 animals 1 hour after instillation.

Irises were not affected by instillation of the test item.

There were no systemic intolerance reactions.

 

The key studies (recently performed according to current guidelines and GLP) did result in very slight skin and slight eye irritation; these slight irritation effects do not require classification. Supporting studies show signs of slight to moderate irritation but do not justify classification.

Justification for selection of skin irritation / corrosion endpoint:
Well conducted study according to GLP

Justification for selection of eye irritation endpoint:
Well conducted study according to GLP

Justification for classification or non-classification

Based on the classification criteria of Annex VI Directive 67/548/EEC or UN/EU GHS, the low level of dermal and ocular irritation (by analogy with FeNaEDTA, CAS 15708-41-5) results in no classification of EDTAFeHNa for skin and eye irritation.