Zinc bis(dinonylnaphthalenesulphonate)

Endpoint summary

Description of key information

Skin irritation/corrosion:

Six rabbits were exposed to the test material for 24 hours. Signs of irritation were observed (redness of the skin), which were not shown to be reversible. The test material is irritant to the rabbit's skin.

Six rabbits were exposed to the test material for 4 hours. No full destruction of the skin was observed. Therefore it can be concluded that the test material is not corrosive.

Eye irritation/corrosion:

In an OECD 405 guideline study with Australian White Rabbits, the test substance caused serious eye irritation that was fully reversible within 14 days following installation into one eye of each of three rabbits. Slight dulling of the cornea was noted for all animals on Day 1 only. Treatment of the eyes with 2% fluorscein 24 hours after test item instillation revealed no corneal epithelial damage. No iridial irritation was observed. Given these results, the test substance should be classified as Category 2A (irritation to eyes) based on GHS/CLP criteria.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation / corrosion, other

Remarks:

existing in-vivo study

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

limited report, non-GLP, test with formulation. limited information on results (no individual data, only 2 observations), The exposure during 24 hours represents a worst case. The information in the report is limited to the information in the summary.

Qualifier:

according to guideline

Guideline:

other: FHSLA, CFR Title 21, para. 191.11

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Bodyweight: 2.3 to 3.0 kg
No further details

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 40% in diluent oil

Duration of treatment / exposure:

24 hours

Observation period:

scored 24 and 72 hours after application

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm2
- Abrasions made over 2-3 cm2
- Type of wrap if used: plastic trunk band to prevent evaporation

REMOVAL OF TEST SUBSTANCE
- Washing (if done):none

SCORING SYSTEM: Draize

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 and 72 h

Score:

ca. 3.66

Reversibility:

not reversible

Remarks on result:

other: score for non-abraded skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 and 72 h

Score:

ca. 0.16

Reversibility:

not reversible

Remarks on result:

other: score for non-abraded skin

Irritant / corrosive response data:

The results are presented for the abraded and non-abraded skin.

Other effects:

none reported

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The test material is irritating to the rabbit's skin.

Executive summary:

Six rabbits were exposed to the test material for 24 hours. Signs of irritation were observed (redness of the skin), which were not shown to be reversible. The test material is irritant.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8 Sept 2016 to 4 Oct 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2012

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Version / remarks:

1998

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Appearance: Dark brown liquid
Batch: 983-130
Purity/Composition: 41% solid (UVCB) in oils At room temperature
Test item storage stable under storage conditions until: 26 May 2018 (expiry date)
pH at concentration of 10% in 80% aqueous IPA: 5.8

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Source: Charles River France, L’Arbresle, France
Number of Animals: 3 males
Age and body weight: At start of dosing, the animals were between 12 and 24 weeks old and body weights were at least 1.5 kg.
Identification: Earmark
Health Inspection: At least prior to dosing. It was ensured that the animals were healthy and that the eyes were free from any abnormality.

Vehicle:

other: 41% in mineral oil

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

Single treatment into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and 7 and 14 days after instillation.

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

3

Details on study design:

The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner 1 week later, after considering the degree of eye irritation observed in the first animal. One hour prior to instillation of the test item, buprenorphine (Buprenodale®, Dechra Ltd., Stoke-on-Trent, United Kingdom) 0.01 mg/kg was administered by subcutaneous injection in order to provide a therapeutic level of systemic analgesia.

Five minutes prior to instillation of the test item, two drops of the topical anesthetic alcaine 0.5% (SA Alcon-Couvreur NV, Puurs, Belgium) were applied to both eyes.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.7

Max. score:

3

Reversibility:

fully reversible within: 14 days

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.7

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Individual Eye Irritation Scores

Animal	Time after dosing	Cornea			Iris	Conjunctivae			Comments
		Opacity (0-4)	Area (0-4)	Fluor area (%)	(0-2)	Redness	Chemosis	Discharge
186^1	1 hour	0	1		0	2	3	3	g
	24 hours	0	0	0	0	3	2	3
	48 hours	0	0		0	2	1	2
	72 hours	0	0		0	2	1	1
	7 days	0	0		0	1	0	0
	14 days	0	0		0	0	0	0
191	1 hour	0	1		0	2	3	3	g
	24 hours	0	0	0	0	3	2	2
	48 hours	0	0		0	2	2	2
	72 hours	0	0		0	2	1	1
	7 days	0	0		0	1	0	0
	14 days	0	0		0	0	0	0
192	1 hour	0	1		0	2	3	3	g
	24 hours	0	0	0	0	3	3	2
	48 hours	0	0		0	3	2	2
	72 hours	0	0		0	2	1	1
	7 days	0	0		0	1	0	0
	14 days	0	0		0	0	0	0

¹Sentinel.

g = Slight dulling of the normal luster of the cornea.

Interpretation of results:

Category 2A (irritating to eyes) based on GHS criteria

Conclusions:

The test item caused serious eye irritation. Effects were fully reversible within 14 days.

Executive summary:

In an OECD 405 guideline study with Australian White Rabbits, the test substance caused serious eye irritation that was fully reversible within 14 days following installation into one eye of each of three rabbits. Slight dulling of the cornea was noted for all animals on Day 1 only. Treatment of the eyes with 2% fluorscein 24 hours after test item instillation revealed no corneal epithelial damage. No iridial irritation was observed. Given these results, the test substance should be classified as Category 2A (irritation to eyes) based on GHS/CLP criteria.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The available studies contain sufficient information to be used for risk assessment and classification and labelling. All tests are performed on a 40% formulation. It is not expected that the diluent used has contributed to the effects if any.

Justification for selection of skin irritation / corrosion endpoint:
Study was conducted prior to GLP regulations but used methods generally consistent with accepted procedures. Exposure duration in both the irritation as well as the corrosion test represent a worst case situation.

Justification for selection of eye irritation endpoint:
Study was conducted according OECD 405 guideline under GLP conditions.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the outcome of the available tests, the test substance needs to classified as skin irritant (CLP category 2, H315: Causes skin irritation) and eye irritant (CLP category 2, H319: Causes serious eye irritation). The non-guideline, non-GLP study from 1978, which showed irreversible effects on the eye, was rejected as an outlier when considered as part of a weight of evidence assessment of all available eye irritation data for the various DNNSA metal salts.