Butanedioic acid, 2-sulfo-, mono(C16-18 and C18-unsatd. alkyl) esters, ammonium sodium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 4-June 24, 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to GLP and valid test methods, therefore the study was considered relevant, adequate and reliable for classification.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

Off. J. Europ. Commun. L 251, 27, 106-108 (1984)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Butanedioic acid,sulfo-, mono (C16-18 and C18-unsatd. alkyl) ester, ammonium sodium salt

EC Number:

604-617-1

Cas Number:

147993-66-6

IUPAC Name:

Butanedioic acid,sulfo-, mono (C16-18 and C18-unsatd. alkyl) ester, ammonium sodium salt

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): Ke 883 B40 (Collector SCO 40); alkyl sulfo succinate, natrium/ammonium-salt
- Physical state: White viscous
- Analytical purity: 40%
- Impurities (identity and concentrations): Not provided
- Composition of test material, percentage of components: See confidential details
- Purity test date: Not provided
- Lot/batch No.: 00052058
- Expiration date of the lot/batch: 1993-03-06
- Stability under test conditions: Pure: stable for at least 1 year
- Storage condition of test material: At room temperature

Test animals

Species:

rabbit

Strain:

other: Kleinrussen, CHbb:HM

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Thomae GmbH, Biberach/D.
- Age at study initiation: Approximately 17 months
- Weight at study initiation: Approximately 2630 g
- Housing: Individual accomodation
- Diet (e.g. ad libitum): Ssniff rabbit diet K4, Ssniff GmbH, Soest/D Batch: 550492/09, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: At least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Approximately 20-25°C
- Humidity (%):Approximately 45-70%
- Air changes (per hr): At least 8 per hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1992-05-04 To:1992-05-24

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

Amount/concentration applied: 0.5 g
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 40%

Duration of treatment / exposure:

4 hours

Observation period:

21 days (22 days for first experimental animal)

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: flank
- % coverage: Not provided
- Type of wrap if used: The semi-occlusive exposure was performed by means of a 6 cm2 adhesive air- and vapor permeable gauze-patch which was fixed by a hypoallergenic adhesive gauze-bandage.

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

SCORING SYSTEM:
Erythema and eschar formation
No erythema 0
Very slight, barely perceptible erythema (-slight-) 1
Well-defined erythema (-weak-) 2
Moderate to severe erythema (-moderate-) 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) (-severe-) 4

Edema formation
No edema 0
Very slight, barely perceptible edema (-slight-) 1
Slight edema, edges of area well defined (-weak-) 2
Moderate edema, raised approx. 1mm (-moderate-) 3
Severe edema, raised more than 1mm and extending beyond the area of exposure (-severe-) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

>= 2

Max. score:

4

Reversibility:

not fully reversible within: 21-22 days

Remarks on result:

other: mean score= 2.22

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

not fully reversible within: 22 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

>= 2

Max. score:

4

Remarks on result:

other: mean score = 2.44

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 22 days

Remarks on result:

other: eschar on day 7 & 14

Results 7

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.33

Max. score:

4

Reversibility:

fully reversible within: 21 days

Remarks on result:

other: brownish discolouration on day 3; eschar on day 7 & 14

Results 8

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.33

Max. score:

4

Reversibility:

fully reversible within: 21 dyas

Remarks on result:

other: brownish discolouration up to 3 days; eschar on day 7 & 14

Any other information on results incl. tables

Table 1. Summary of the symptoms

dermal reactions	mean value (24/48/72h)	Number of animals
erythema	≥2	3
edema	≥2	3

 

Table 2. Evaluation of the skin reaction

Animal no./flank	Hours after exposure
	1		24		48		72
	er	ed	er	ed	er	ed	er	ed
1251/r	2	1	2	2	3	3	3	3
1256/l	1	1	2	2	2	2	2	2 b
1573/l	1	1	2	3 b	2	2 b	2	2 b

 

Animal no./flank	Days after exposure
	7		14		21/22^*	er	ed
1251/r	ᴓ	es	ᴓ	es	ᴓ	1	0
1256/l	ᴓ	es	ᴓ	es	ᴓ	0	0
1573/l	ᴓ	es	ᴓ	es	+	0	0

 

r = right flank                   ed = edema                         + = reversible
l = left flank                      er = erythema                    ᴓ = irreversible
* animal 1251                   es = eschar b = brownish discolouration

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test item proved to be “moderately irritating” on the skin according to the conditions applied.

Executive summary:

The test item, containing 40% active ingredient, was tested for acute dermal irritation on the dorsal shaved skin of the rabbit in a dose of 0.5 g. The contact time under semi-occlusive conditions lasted 4 hours. According to the guidelines in a preliminary study 1 animal was treated first because of the risk of severe skin injury. Moderate effects of the skin were observed. After 4 weeks 2 other experimental animals were treated. In all animals moderate erythema and edema were observed during the first 72 hours after exposure. Mean 24 -72h scores were 2.22/4 for erythema and 2.44/4 for edema. Two experimental animals showed a brownish discolouration additionally. The skin of all animals showed eschar on day seven and day 14 after exposure. The irritation effects (slight erythema) of 2 experimental animals persisted longer than 21 days. The observed effects of the other experimental animal reversed completely within 21 days.