Reaction mass of 4-hydroxybenzene-1,3-disulphonic acid and 4-hydroxybenzenesulphonic acid and sulphuric acid and water

Endpoint summary

Description of key information

Corrosive

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 based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline, GLP study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

physiological saline

Controls:

yes, concurrent no treatment

Duration of treatment / exposure:

4 hour

Observation period:

7 days

Number of animals:

1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-72 hr

Score:

3.7 - 4

Reversibility:

not fully reversible within: 7 days

Other effects:

Mean Edema score was 2.0
Brown discolouration

3 additional animals were exposed for 3 minutes each. The mean erythema score was 0.6 and the mean edema score was 0. Effect was reversible within 72 hours.

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is corrosive to the skin. Washing immediately after exposure significantly reduced the severity and duration of the effect.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

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:

1962

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Not a guideline study and not all details available

Principles of method if other than guideline:

9 animals were exposed to 0.1 mL of the test substance for 5, 10 or 30 seconds (3 animals for each duration) and then eyes were rinsed. The Draize, Woodard and Calvery scoring system was used. Observations were at 1, 4, 24, 48, 72, 120 and 168 hours following exposure. Reversibility was determined up to 14 days post exposure.

GLP compliance:

no

Species:

rabbit

Strain:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Duration of treatment / exposure:

5, 10 or 30 seconds

Observation period (in vivo):

168 hours for scoring and 14 days for reversibility

Number of animals or in vitro replicates:

3 at each treatment duration

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 5 second exposure

Score:

>= 83.6 - < 110

Max. score:

110

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: overall irritation score was 83.6 out of 110 at 5 second exposure, and 110 out of 110 at both 10 and 30 second exposures

Other effects:

With 5 second exposure there was copious discharge, swelling with lids about half closed, severe redness of conjunctivae, and opacity sufficient to render the iris invisible, all developed within a few minutes. After 14 days there is moderate edema and discharge, moderately severe erythema, and opalescent areas. The iris is reacting to light.
With 10 second exposure, the response was similar to 5 seconds except the iris seems to be destroyed at 14 days. Maximum score of 110 reached in 4 hours.
With 30 second exposure, the response was similar to 10 seconds but with the area of severe edema and congestion extending for a greater distance around the eye.
The cornea became opalescent in 4-8 seconds and the swelling was rapid in all exposures.

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is corrosive to the eye even with short (i.e., 5-30 second) exposure.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The aromatic sulphonic acids, as represented by toluene-4-sulphonic acid (CAS No. 104-15-4) and hydroxybenzenesulphonic acid (CAS No. 1333-39-7) are corrosive to the skin and eye. Also sulphuric acid, the main component is corrosive for skin and eye. Therefore the multicomponent is consequently classified

A GLP guideline skin irritation study with toluene-4-sulphonic acid conducted in 1988 indicated corrosive properties after 4 hours of exposure; and the effects were not reversible after 7 days. 3-minute exposures followed by washing with water resulted in a much less severe effect that was reversible within 72 hours. During the test on sensitisation the primary skin irritation effect of 0.01 -20% solutions of toluene-4-sulphonic acid

monohydrate in 0.9% NaCl solution was studied. The animals was exposed 24 hours to an occlusive application. An irritation effect was only found with 20%

toluene-4-sulphonic acid

, but in a study by Loden et al (1985) with rabbits, without occlusion and after 4 hours, the same concentration in pure water solution caused burns

A 1962, non-guideline eye irritation study with a 65% solution hydroxybenzenesulphonic acid indicated corrosion of the eye even after 5 seconds of exposure. There was no reversibility indicated within 14 days.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on existing tests the substance is classificated as "Corrosive" following Regulation 1272/2008. Based on existing studies a tested concentration < 20% didn't caused burns or irreversible effect. But the main component of the multiconsituent is sulphuric acid, for which the limit concentration is set to 15%, Therefore a concentration limit of 15% is set, under that the substance can be classified as "Irritant"