Alkylated Naphthalene Sulphonic Acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

existing study

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Apri1 9 -16, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study similar to the OECD guideline under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

other: liquid

Details on test material:

- Identity: Alkylnaphthalene sulfonic acid
- Physical state: Dark brown viscous liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst. MA
- Age at study initiation: young adult
- Weight at study initiation: not indicated
- Housing: individually
- Diet: Pelleted Purina Rabbit Chow #5326, ad libitum
- Water: Filtered tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23°C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours and 7 days after patch removal

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: 4-p1y gauze pad wrapped with 3 inch Micropore tape

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

SCORING SYSTEM:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: 4-p1y gauze pad wrapped with 3 inch Micropore tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): removal of residual test substance with mineral oil, acetone and water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-72 h

Score:

ca. 1.6

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-72 h

Score:

ca. 0.3

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

not irritant, no signs of corrosion

Other effects:

no signs of gross toxicity, adverse pharmacologic effects or abnormal behavior

Any other information on results incl. tables

Animal no	1					2					3
Day	1	24	48	72	7	1	24	48	72	7	1	24	48	72	7
erythema	2	2	1	1	0	2	2	2	1	0	2	2	2	2	0
oedema	0	0	0	0	0	0	0	0	0	0	1	1	1	1	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is not irritating to the skin.

Executive summary:

The test substance was applied on the skin of 3 rabbits. No signs of irritation were observed during the 7 day observation period. According to the CLP criteria the test substance is not considered to be irritant to the skin.