Sodium cumenesulphonate

Endpoint summary

Description of key information

-The acute eye irritation study indicates that Sodium cumenesulphonate as 60% solution

caused mild irritation.

 

Result: Slight eye irritating at 60% solution

Effects on eye irritation: slightly irritating

 

 -The results indicate that Sodium cumenesulphonate is not irritating to the skin.

The test substance was not irritating to skin. No irritation was observed; all scores were “0”.

 

Result: not irritating to skin

Conclusion

Sodium cumenesulphonate is not irritating to the skin and slightly irritating to the eye.

 

Result: Slight eye irritating at 60% solution

Effects on eye irritation: slightly irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Specific details on test material used for the study:

CAS Number: 28348-53-0
Identity: Cumene sulfonic acid, sodium salt
Purity: 96.0%
Remarks: 60% aqueous solution

Species:

rabbit

Strain:

other: Small White Russian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.2 - 2.4 kg
- Housing: single housing in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K4 complete feed for rabbits, ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: Aqua dist.

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm³
-Concentration: 60% in aqua dist. (paste)

Duration of treatment / exposure:

4 hours

Observation period:

72 hours after patch removal

Number of animals:

6 (3 male, 3 female)

Details on study design:

TEST SITE
- Area of exposure: 6 cm² of shaved skin of the dorsal and lateral parts of the trunk of the animals
- % coverage: not mentioned
- Type of wrap if used: on the application area a mull patch (2,5 x 2,5 cm) was placed, which was covered with a polyethylen film (6 x 6 cm). The application area was then immobilised with an elastic dressing


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with distilled water
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to OECD guideline 404

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

AVERAGE SCORE
- Erythema: 0
- Edema: 0

Table: Irritant/corrosive response data for each animal at each observation time of each animal from the test

 

Score at time point / Reversibility	Erythema	Edema
	Max. score:	Max. score:
60 min	0/0/0/0/0/0	0/0/0/0/0/0
24 h	0/0/0/0/0/0	0/0/0/0/0/0
48 h	0/0/0/0/0/0	0/0/0/0/0/0
72 h	0/0/0/0/0/0	0/0/0/0/0/0
Average 24h, 48h, 72h	0	0
Reversibility*)	-	-
Average time (unit) for reversion

Interpretation of results:

other: not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test substance was not irritating to skin. No irritation was observed; all scores were “0”.

Executive summary:

The test substance was not irritating to skin. No irritation was observed; all scores were “0”.

Reference 2

Endpoint:

skin irritation: 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:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

Test Substance
CAS Number: 28348-53-0
Identity: Cumene sulfonic acid, sodium salt
Purity: 96.0%

Species:

rabbit

Strain:

other: Small White Russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.0 - 2.4 kg
- Housing: conventional, singly in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GembH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye

Amount / concentration applied:

Application of 50 mg into the conjunctival sac of one eye.

Duration of treatment / exposure:

The test substance was not washed out of the eyes of the treated animals and remained until the test was terminated.

Observation period (in vivo):

1, 24, 48 and 72 hours, and 6, 8 and 14 days after application

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
Test substance was not washed out


SCORING SYSTEM: according to guideline


TOOL USED TO ASSESS SCORE: ophthalmic lamp, the disappearance of corneal findings was checked by adding Sodium-Fluorescein

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.44

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.94

Max. score:

3

Reversibility:

fully reversible within: 6 days

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

Slight irritation at 60% solution.Eye irritation is slight .

Table: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	1/1/1/1/1/1	0/0/0/0/0/0	1/1/1/1/1/1	1/1/1/3/1/2
24 h	1/1/1/1/1/1	1/1/1/1/1/1	2/1/1/1/2/1	1/1/0/2/1/0
48 h	1/1/1/1/1/1	0/1/0/1/0/0	1/1/1/1/1/1	0/0/0/1/0/0
72 h	1/1/1/1/1/1	0/0/0/0/0/0	0/1/0/1/1/0	0/0/0/0/0/0
Average 24h, 48h, 72h	1.00	0.44	0.94	0.33
Reversibility*)	c.	c.	c.	c.
Average time (unit) for reversion	14 days	72 hours	6 days	72 hours

 

*) Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible

Animals #1 -3: male; #4 -6: fema

Interpretation of results:

other: Slight irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Slight irritation at 60% solution.Eye irritation is slight .
Result: Slight irritating at 60% solution

Executive summary:

 

 

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

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

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Conclusion

Sodium cumenesulphonate is not irritating to the skin and slightly irritating to the eye.

 

Result: Slight eye irritating at 60% solution

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Based on the hazard assessment of Sodium cumenesulphonate in section 2.1 and 2.2. in IUCLID 6., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health” andaccording to the criteria described in Directive 67/548 and in the CLP Regulation:

Directive 67/548

Skin Corrosivity C R35 Causes severe burns R34 Causes burns Skin Irritation Xi R38 Irritating to skin R43 May cause sensitization by skin contact Eye Irritation (Ocular Lesions) Xi R36 Irritating to eyes R37 irritating to respiratory system R41 Risk of serious damage to eyes R36/37/38 Irritating to eyes, respiratory system and skin. R36/38 Irritating to eyes and skin.

CLP

Skin Corrosivity H314 Skin Corr 1A Causes severe skin burns and eye damage H314 Skin Corr 1B Causes severe skin burns and eye damage Skin Irritation H315 Skin Irrit. 2 Causes skin irritation H317 Skin Sens. 1 May cause an allergic skin reaction Eye Irritation (Ocular Lesions) Xi H319 Eye Irrit. 2 Causes serious eye irritation H318 Eye Dam. 1 Causes serious eye damage H335 STOT SE 3 May cause respiratory irritation

It is concluded that the substance Sodium cumenesulphonate meet the criteria to be classified for human health hazards for Dermal-local effect :

H319 Eye Irrit. 2 Causes serious eye irritation,