Benzenesulfonic acid, 4-C15-16-sec-alkyl derivs.

Endpoint summary

Description of key information

The read-across source substance LAB Sulfonic Acid was tested and found to be irritating to both the skin and eyes of test animals. Skin and eye irritation studies in rabbits indicate that the read-across source substance LAB Sulfonic Acid is corrosive to skin and a persistent moderate irritant and damaging to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

see read-across document

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: Mean of 1, 24, 48 and 72 hours.

Score:

5.25

Max. score:

6

Reversibility:

not reversible

Remarks on result:

other: highly irritating

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 48, 72 hr readings

Score:

5.33

Max. score:

8

Reversibility:

not fully reversible within: 14 days

Other effects:

Significant reddening effects were observed at all times and were persistent. Bloody wounds and scar formation were observed through at least observation day 9.

Results of Skin Irritation Study in Rabbits

Observation	Endpoint	Male 11499	Male 11887	Male 11901	Female 11580	Female 11658	Female 11802
1 hr	Erythema	4 X	4 X	4 X	4 X	4 X	4 X
1 hr	Edema	1	1	1	1	1	1
24 hrs	Erythema	4 X	4 X	4 X	4 X	4 X	4 X
24 hrs	Edema	1	1	1	1	1	1
48 hrs	Erythema	4 X	4 X	4 X	4 X *	4 X	4 X *
48 hrs	Edema	1	1	1	1	1	1
72 hrs	Erythema	4 *	4 *	4 X *	4 X *	4 *	4 *
72 hrs	Edema	2	2	2	2	2	2
6 days	Erythema	4 +	4 *	4 *	4 * -	4 +	4 + -
6 days	Edema	2	2	2	2	2	2
9 days	Erythema	W	W	W	+	W	+
9 days	Edema	C N	C N	N		N	W
14 days	Erythema	N	N	N	N	N	N
14 days	Edema	N	N	N	N	N	N

X - Necrosis in application area bordered by swelling

* - Application area hardened

+ - Wavy crust

- - Application area paper-like

W - Bloody wounds

C - Crust formation

N - Scar formation

Interpretation of results:

Category 1C (corrosive) based on GHS criteria

Conclusions:

Result: Highly irritating

Executive summary:

The shaved backs of three male and three female rabbits were exposed for 4 hours to 0.5 ml of the test substance and observed for up to 14 days. Significant reddening was observed throughout at least day 9. Swelling was perceptible throughout and appeared to become more noticeable with time. Bloody wounds and scar formation were observed through at least observation day 9. The test substance is considered highly irritating to the skin of rabbits. The test substance is considered corrosive to skin according to OECD GHS guidelines.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

see read-across document

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48, and 72 hrs and 6 days

Score:

46.9

Reversibility:

not fully reversible within: 6 days

Remarks on result:

other: moderately irritating

Irritant / corrosive response data:

Results indicated a moderate irritancy, but because of the intensity of the necrosis formation, the study was stopped at day 6.

Results of Eye Irritation Study in Rabbits

Observation	Endpoint	Male 11655	Male 11715	Male 11771	Female 11798	Female 11804	Female 11838
1 hr	Cornea - degree	1	1	2	2	2	1
1 hr	Cornea - range	4	4	4	4	4	4
1 hr	Iris	1X	1X	1X	1X	1X	1X
1 hr	Conjunctiva - redness	3N	3N	3N	2N	3N	3N
1 hr	Conjunctiva - edema	1	1	1	1	2	2
1 hr	Conjunctiva - exsudation	3	3	3	3	3	3
24 hrs	Cornea -degree	1	1	2	2	3C	1
24 hrs	Cornea - range	4	4	4	4	2	4
24 hrs	Iris	1*	1*	1*	1*	1*-	1*
24 hrs	Conjunctiva - redness	3N	3N	3N	3N	3N S	3N
24 hrs	Conjunctiva - edema	2	2	2	2	2	3
24 hrs	Conjunctiva - exsudation	2	2	2	2	2	2
48 hrs	Cornea ¿ degree	1	1	2	2	3C	1
48 hrs	Cornea - range	4	4	4	4	2	4
48 hrs	Iris	1*	1*	1*	1*	1*-	1*
48 hrs	Conjunctiva ¿ redness	3N S	3N	3N S	3N S	3N S	3N S
48 hrs	Conjunctiva ¿ edema	2	1	1	1	2	3
48 hrs	Conjunctiva - exsudation	2	2	2	2	2	2
72 hrs	Cornea - degree	1	1	1	2	4C	1
72 hrs	Cornea - range	4	2	4	4	2	4
72 hrs	Iris	1X	1X	1*	1*	1*-	1*
72 hrs	Conjunctiva - redness	3N S	3N S	3N S	3N S	3N S	3N S
72 hrs	Conjunctiva - edema	2	2	2	2	2	2
72 hrs	Conjunctiva - exsudation	2	2	2	2	2	2
6 days	Cornea - degree	2	2	2	2	4C	2
6 days	Cornea -range	3	3	2	3	2	4
6 days	Iris	1X	1X	1*	1*	1*-	1*
6 days	Conjunctiva - redness	3N S L	3N L	3N L H	3N S L	3N S L	3N S L
6 days	Conjunctiva - edema	2	2	2	2	2	2
6 days	Conjunctiva - exsudation	2	1	2	2	2	2

C - Cornea cloudy

X - Parts of the iris turned red

* - Iris turned red

- - Retarded iris reaction

N - Necrosis and corrosion of the conjunctiva

S - Secretion formation

L - Lids became encrusted

H - Holding head inclined

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Result: moderately irritating

Executive summary:

The eyes of six rabbits were treated with the test substance and observed for six days. Results indicate that the substance was moderately irritating but because of the intensity of the necrosis formation the study was stopped at day 6.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

The read-across source substance LAB Sulfonic Acid was tested and found to be irritating to both the skin and eyes of test animals. In skin, significant reddening was observed throughout at least day 9. Swelling was perceptible throughout and appeared to become more noticeable with time. Bloody wounds and scar formation were observed through at least observation day 9. The test substance is considered highly irritating to the skin of rabbits. In eyes, LAB Sulfonic Acid was moderately irritating but because of the intensity of the necrosis formation the study was stopped at day 6. According to these results for the read-across source substance, Benzenesulfonic acid, 4-C15-16-sec-alkyl derivs. is classified as CLP category 1C for skin irritation (H314: Causes severe skin burns and eye damage) and CLP category 1 for eye irritation (H318: Causes serious eye damage).

The first key study (Murmann 1984) examined the potential for the read-across source substance to cause dermal irritation/corrosivity. The shaved backs of three male and three female rabbits were exposed for 4 hours to 0.5 ml of the LAB Sulfonic Acid and observed for up to 14 days. Significant reddening was observed throughout at least day 9. Swelling was perceptible throughout and appeared to become more noticeable with time. Bloody wounds and scar formation were observed through at least observation day 9. The test substance is considered a Category 1C corrosive according to CLP guidelines based on persistent irritation (H314: Causes severe skin burns and eye damage).

The second key study (Murmann 1984) also examined the potential of the read-across source substance to cause irritation/corrosivity to eyes. The eyes of six rabbits were treated with LAB Sulfonic Acid and observed for six days. Treatment was to the right eye with lower lid removed. The left eye was untreated and served as the control. The eyes were not washed out during the test. Observations were made at 1, 24, 48, and 72 hours and at 6 days after application. Results indicate that the substance was moderately irritating but because of the intensity of the necrosis formation the study was stopped at day 6. According to these results, the read-across source substance is a category 1 eye irritant according to CLP because it caused damage that was not reversible within the 6 days of the study (H318: Causes serious eye damage).

Effects on skin irritation/corrosion: highly irritating

Effects on eye irritation: moderately irritating