Dinonylnaphthalenedisulphonic acid

Endpoint summary

Description of key information

Formulations of the substance were tested in skin and eye irritation tests. The formulation was not irritating to the skin (Huntingdon 1977), but severely irritating to the eyes (PSL 1978). 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin corrosion: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation, 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: non-GLP study with limited information on method and results. The study is used in a worst case approach. The information in the report is limited to the information in the summary.

Qualifier:

according to guideline

Guideline:

other: FHSLA J CFR, Tit 1e 21, para. 191. 12

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS: no data

ENVIRONMENTAL CONDITIONS: no data

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 55%

Observation period (in vivo):

scored at 24, 48, 72 hours and 4, 7 and 14 days

Number of animals or in vitro replicates:

6

Details on study design:

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

SCORING SYSTEM: scoring to scale system (similar to Draize)
cornea: (severity + area) * 5
iris * 5
conjunctivae: (redness + chemosis+ discharge) *2

TOOL USED TO ASSESS SCORE: not indicated

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

14 d

Score:

0

Max. score:

3

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

14 d

Score:

1

Max. score:

3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

14 d

Score:

0

Max. score:

3

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

14 d

Score:

3

Max. score:

3

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

14 d

Score:

1.5

Max. score:

3

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

14 d

Score:

1

Max. score:

3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

14 d

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #2

Time point:

14 d

Score:

1

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #3

Time point:

14 d

Score:

1

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #4

Time point:

14 d

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #5

Time point:

14 d

Score:

1

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #6

Time point:

14 d

Score:

0

Max. score:

2

Irritant / corrosive response data:

irritant

Other effects:

none reported

Animal no	1						2						3
	24	48	72	4	7	14	24	48	72	4	7	14	24	48	72	4	7	14
cornea	3	3	3	1	0	0	3	3	0	1	1	1	3	1	1	1	1	0
iris	2	1	1	1	0	0	2	0	1	1	1	1	2	2	1	1	1	1
conjunctivae	effects at all time points in all animals

 

Animal no	4						5						6
	24	48	72	4	7	14	24	48	72	4	7	14	24	48	72	4	7	14
cornea	3	3	2	3	3	3	3	3	3	3	2	1.5	3	1	1	1	1	1
iris	2	2	2	1	0	0	2	2	2	2	1	1	2	0	1	1	0	0
conjunctivae	effects at all time points in all animals

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance is a severe eye irritant

Executive summary:

The test substance was applied to the eye of 6 rabbits. Severe effects on cornea and iris were observed during the 14 day observation period. The effects including those on the conjunctivae were not fully reversible. The substance is considered to be a severe eye irritant and has to be classified as H318.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Formulations of the substance were tested in skin and eye irritation tests. The formulation was not irritating to the skin, but severely irritating to the eyes. At the water solubility level the substance was found to be a strong acid with pH 1-2. Therefore it is concluded that in a worst case the substance is considered corrosive.

Justification for selection of eye irritation endpoint:
study similar to the guideline

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Based on the pH of the substance at the water solubility level (1 -2), it can be concluded that classification as corrosive is required according to CLP (Regulation EC No 1272/2008). The substance is classified as H314 (Causes severe skin burns and eye damage).