4-amino-N-(2-ethylhexyl)benzenesulphonamide

Endpoint summary

Description of key information

Skin irritation: with 20 h exposure time erythema grade 1 were observed at animal #1, and erythema grade 0 were observed at animal #2 (max. grade 4) after 24 h; effects fully reversible within 8 days. 
Eye irritation: conjunctivae score 2 (max. grade 4) was observed for both test animals; effects fully reversible within 8 days. 
Not to be classified as skin or eye irritating.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976-04-28 to 1977-06-07

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Scientifically acceptable study report

Qualifier:

according to guideline

Guideline:

other: BASF-internal standard

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: animal #1 3.07 kg, animal #2 3.22 kg
- Diet: Ssniff

IN-LIFE DATES: From: 1976-03-24 To: 1976-05-06

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: untreated skin of the animals

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): about 1 g
- Concentration (if solution): 50% aqueous test substance preparation

Duration of treatment / exposure:

20 h

Observation period:

8 d

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: ear 2,5 cm x 2.5 cm; back area not specified, according to study report "application by a cotton ball"
- Type of wrap if used: ear: cotton lobes; back: cotton ball

REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was washed off
- Time after start of exposure: after 20 h

SCORING SYSTEM:
Observed effects: observed were the parameters erythema, edema, scaling, and necrosis
Grading system for redness and edema: The data reported have to be converted into presently used numerical grading system as given in the following table
"reizlos" (no symptom) Ø, "fraglich" (questionable) (+): considered as equivalent to grade 0 (no irritating effect) according to OECD Draize scheme
"leicht" (slight) +: considered as equivalent to grade 1 (very slight effect) according to OECD Draize scheme
"stark" (marked) ++: considered as equivalent to grade 2 (well-defined effect) effect according to OECD Draize scheme
"sehr stark" (severe) +++: considered as equivalent to grade ≥3 (severe effect) according to OECD Draize scheme

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: application to back

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: application to back

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: application to back

Irritant / corrosive response data:

Application to back for 20 h resulted in grade 1 erythema after 24 h for one of the two test animals, effects observed to be fully reversible on day 8 (other animal without effect).
Application to ear without observed effects at any point in time.

Table of results (20 h application to back) based on grading system as applied in the study report

  

	time	animal 1	animal 2
erythema	24 h	+	(+)
	8 d	Ø	Ø
edema	24 h	Ø	Ø
	8 d	Ø	Ø
scaling	24 h	Ø	Ø
	8 d	Ø	Ø

 

Table of results (20 h application to back) translated into the grading system as applied by the Draize scheme

  

	time	animal 1	animal 2
erythema	24 h	1	0
	8 d	0	0
edema	24 h	0	0
	8 d	0	0
scaling	24 h	0	0
	8 d	0	0

 

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not 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:

1976-04-28 to 1977-06-07

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Scientifically acceptable study report

Qualifier:

according to guideline

Guideline:

other: BASF-internal standard

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: animal #1 2.99 kg, animal #2 2.82 kg
- Diet: Ssniff

IN-LIFE DATES: From: 1976-03-24 To: 1976-04-01

Vehicle:

unchanged (no vehicle)

Controls:

other: other eye of test animal treated was with talcum powder

Amount / concentration applied:

about 50 mm3, i.e. ca. 50 mg

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was not washed out

SCORING SYSTEM: observed were the parameters redness and chemosis of conjunctivae, and corneal opacity

Grading system for redness and edema: The data reported have to be converted into presently used numerical grading system as given in the following table
"reizlos" (no symptom) Ø, "fraglich" (questionable) (+): considered as equivalent to grade 0 (no irritating effect) according to OECD Draize scheme
"leicht" (slight) +: considered as equivalent to grade 1 (very slight effect) according to OECD Draize scheme
"stark" (marked) ++: considered as equivalent to grade 2 (well-defined effect) effect according to OECD Draize scheme
"sehr stark" (severe) +++: considered as equivalent to grade ≥3 (severe effect) according to OECD Draize scheme

Grading system for iritis: iritis + or ++ equals Draize scheme grade 1 or 2, respectively.

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: in addition a "smeary layer" was reported at 24 h

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Irritant / corrosive response data:

Test item treatment: Slight conjunctival redness was observed at both test animals after 1 h and after 24 h; effects observed to be fully reversible after 8 d.
Control eye treatment with talcum: Control eye of both animals showed slight conjunctival redness after 1 h and after 24 h such as the eye treated with test item; effects also observed to be fully reversible after 8 d. Both control eyes furthermore showed edema after 1 h, grade 3 for animal #1 and grade 2 for animal #2.

Table of results based on grading system as applied in the study report

   

	time	animal 1	animal 2
conjunctivae	1 h	+	+
	24 h	+	+
	8 d	Ø	Ø
chemosis	1 h	Ø	Ø
	24 h	Ø	Ø
	8 d	Ø	Ø
cornea	1 h	Ø	Ø
	24 h	Ø	Ø
	8 d	Ø	Ø

 

Table of results based on grading system as applied by the Draize scheme

   

	time	animal 1	animal 2
conjunctivae	1 h	1	1
	24 h	1	1
	8 d	0	0
chemosis	1 h	0	0
	24 h	0	0
	8 d	0	0
cornea	1 h	0	0
	24 h	0	0
	8 d	0	0

 

 

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation:

The skin irritation was tested in 1977 by a study according to BASF internal standard. The test substance was applied in a single dose (occlusive) to the clipped skin (back and ear) of an experimental animal for 20 h (test item was washed off); untreated skin areas of the test animal served as the control. The degree of irritation was read and scored at 1 min, 5 min, and 15 min, 24 h and 8 days. With 20 h exposure time erythema grade 1 was observed for animal #1, and erythema grade 0 was observed for animal #2 (max. grade 4) after 24 h. These effects were observed to be fully reversible within 8 days.

Eye irritation:

The eye irritation was tested in 1977 by a study according to BASF internal standard. The test substance was applied in a single dose to one of the eyes of the two experimental animals; the other eye treated with talcum served as the control, respectively. The degree of eye irritation (conjunctival redness and chemosis, corneal opacity) was evaluated by scoring lesions of conjunctiva and cornea at 24 h and 8 days. A slight reddening of the conjunctivae (grade 1) was observed at both test animals after 24 h. The effect proved to be fully reversible within the 8 days observation period.

Justification for selection of skin irritation / corrosion endpoint:
Scientifically acceptable study report

Justification for selection of eye irritation endpoint:
Scientifically acceptable study report

Justification for classification or non-classification

Skin irritation

 

Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under Directive 67/548/EEC. As a result the substance is not considered to be classified for skin irritation under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The reported effects were less severe than the classification criteria as set out in EC Regulation 1272/2008 (mean value of ≥ 2.3 - ≤ 4.0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 h after patch removal). The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for skin irritation under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.

 

 

Eye irritation

 

Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under Directive 67/548/EEC. As a result and according to the harmonised Annex I classification the substance is not considered to be classified for eye irritation under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The reported effects were less severe than the minimum classification criteria for conjunctival redness >=2 as set out in EC Regulation 1272/2008. No further eye irritating effect observed. The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is considered not to be classified for eye irritation.