Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997-09-11 to 1997-09-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Acetic acid, 2-sulfo-, mono-C12-14(even numbered)-alkyl esters, sodium salt
EC Number:
939-512-2
Cas Number:
85681-55-6
IUPAC Name:
Acetic acid, 2-sulfo-, mono-C12-14(even numbered)-alkyl esters, sodium salt
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): LATHANOL LAL
- Lot/batch No.: Lot #7-20041
- Substance type: white powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kuiper Rabbitry, Gary, Indiana
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 1850 - 2320 g
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
Temperature, humidity and light controlled room (DHEW publication No. 86-23 (NIH))

IN-LIFE DATES: From: 1997-09-11 To: 1997-09-25

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: moistened with water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
Duration of treatment / exposure:
4 hours.
Observation period:
14 days
Number of animals:
6 males
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: 2 layer gauze patch secured with non-irritating Kendall Curity Standard Porus tape covered with a semiocclusive plastic overwrap secured with non-irritating Kendall Curity Standard Porus tape

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

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 4.5, 24, 48 and 72 h
Score:
2.09
Max. score:
8
Reversibility:
fully reversible
Remarks:
by 336h observation period.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.6
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7d
Other effects:
No data

Any other information on results incl. tables

Table 1: Individual irritation scores

Rabbit Number

Sex

ER

4.5

ED

4.5

ER

24

ED

24

ER

48

ED

48

ER

72

ED

72

ER

168

ED

168

ER

336

ED

336

ER Mean totals (24, 48, 72 hours)

ED Mean totals (24, 48, 72 hours)

285

M

1

0

1

0

1

0

1

0

0

0

0

0

1

0

286

M

1

1

0

0

0

0

0

0

0

0

0

0

0

0

287

M

1

2

1

1

2

0

2

0

0

0

0

0

1.6

0.3

288

M

1

2

2

1

2

0

2

0

0

0

0

0

2

0.3

289

M

1

2

2

1

2

0

2

0

0

0

0

0

2

0.3

290

M

1

2

2

1

3

1

3

1

1

0

0

0

2.67

1

Mean totals (24, 48, 72 hours)

1.5

0.3

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material does not meet the criteria for classification as a skin irritant as defined in the EU CLP Regulation (EC) No. 1272/2008 under the conditions of the study.
Executive summary:

In an OECD 404 Guideline study, 0.5 g of test material moistened with water was applied to the shaved test site on each of six New Zealand white rabbits (male) and covered with a 2 layer gauze patch secured with non-irritating Kendall Curity Standard Porus tape covered with a semiocclusive plastic overwrap secured with non-irritating Kendall Curity Standard Porus tape for 4 hours. After 4 hours the test sites were wiped with a damp cloth. The sites were examined for erythema and edema using Draize method of scoring at 24, 48 and 72 hours, then 168 and 336 hours.

Semi occlusive 4 hour exposure to 0.5g of the test material produced erythema and/or oedema in 5 of the 6 test animals at 24 hours. At 72 hours 5 out of 6 animals still showed signs of erythema but oedema was observed in only one animal . All skin reactions were reversed by the 336 hour observation. The mean erythema score over the 24, 48 and 72 hour period was 1.5 and the mean oedema score over the same period was 0.3.

The test material does not require classification for skin irritation according to EU the CLP Regulation 1272/2008.