Alkylated Naphthalene Sulphonic Acid

Endpoint summary

Description of key information

The test substance was applied on the skin of 3 rabbits. No signs of irritation were observed during the 7 day observation period (PSL, 2001).
The test substance was shown to be irritant to the eyes when applied in the eyes of 3 rabbits. The effects were reversible after 7 days (PSL, 2001)
Studies with formulations of the analogue DNNSA showed that this substance is not irritating to the skin and ia severe eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

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

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

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
The key study is similar to a guideline study and performed under GLP

Justification for selection of eye irritation endpoint:
Key study according to the guideline and performed under GLP

Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the study results the substance is considered non-irritant to the skin, but irritating to the eyes. According to CLP (Regulation EC No 1272/2008) the substance needs to be classified H319 (category 2: Causes serious eye irritation)