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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
from 11 March 1994 to 29 June 2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was performed on the analogue substance "Reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda" (Commercial name is Aerosol OS in the current study) (for justification of read-across between the registered substance and its analogue, please refer to corresponding assessment report in Section 13). The study is sufficiently documented. No certificate of analysis is available.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
See confidential details on test material section

Test animals

Species:
rabbit
Strain:
other: New Zealand Albino
Details on test animals and environmental conditions:
TEST ANIMALS:
- Source: Animals were received from Ace Animals on 1/18, 2/15 and 2/22/94.
- Age at study initiation: The animals were born the week of 10/24 through 12/12/93.
- Weight at study initiation: 2.2 - 2.7 kg
- Housing: The animals were housed 1/cage in suspended cages. Bedding was placed beneath the cages and changed at least three times/week.
- Diet (e.g. ad libitum): Fresh Purina Rabbit Chow (Diet # 5321)
- Water (e.g. ad libitum): Water was available ad libitum.
- Acclimation period: three days

ENVIRONMENTAL CONDITIONS:
- Temperature (°C): No data on temperature but the animal room was temperature controlled.
- Humidity (%): data not available
- Air changes (per hr): data not available
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: data not available

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped free of hair, intact or abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Test material: Amount applied: 0.5 g/site (dry weight of the test article). The test article was moistened with distilled water (made pasty) after application .
pH: data not available
Duration of treatment / exposure:
4 hour(s)
Observation period:
At 3 min, 1, 4, 24, 48, 72 hours and on day 7 after patch removal
Number of animals:
3
Details on study design:
TEST SITE:
- Area of exposure: disk of ca. 2-3 cm of diameter
- % coverage: data not available
- Type of wrap if used: two 2.5 cm square gauze patch which were secured with adhesive tape. The torso was wrapped with plastic and secured with adhesive tape.

REMOVAL OF TEST SUBSTANCE:
- Washing: any residual test article was washed off with distilled water prior to dermal observations.
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to Draize
- Erythema and Eschar Formation:
No erythema -> 0
Very slight erythema (barely perceptible) ->1
Well defined erythema -> 2
Moderate to severe erythema -> 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema -> 4

- Oedema Formation:
No oedema -> 0
Very slight oedema (barely perceptible) -> 1
Slight oedema (edges of area well defined by definite raising) -> 2
Moderate oedema (raised approximately 1 mm) -> 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) -> 4

- Primary Dermal Irritation Index = (Sum of individual Erythema scores + Sum of individual Edema scores) / 12

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0 - 1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: intact skin. Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.33 and 1.7.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin. Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.33 and 1.0.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.17
Max. score:
8
Reversibility:
fully reversible within: 72 hours or 7 days
Remarks on result:
other: scarified and intact skin
Irritant / corrosive response data:
Erythema, absent at 3 minutes post dose, was absent to slight at one and four hours. At 24 and 48 hours after patch removal, erythema was absent to well defined. At 72 hours erythema was absent to slight and absent on day 7. Edema, absent at 3 minutes post dose, was absent to slight at one and four hours. At 24 hours after patch removal, edema was absent to well defined. Edema was absent to slight at 48 hours and absent at 72 hours and on day 7. The modified primary irritation index is 1.17.

SEE INDIVIDUAL SCORES IN TABLE 1 BELOW
Other effects:
There were no signs of systemic toxicity noted during the observation period.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

normal

scarified

normal

scarified

3 min

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

1 hr

0 / 0 / 1

1 / 0 / 0

0 / 0 / 1

0 / 0 / 0

4 hrs

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 1

24 hrs

0 / 1 / 2

1 / 0 / 2

0 / 1 / 2

1 / 0 / 2

48 hrs

0 / 0 / 2

0 / 0 / 2

0 / 0 / 1

1 / 0 / 1

72 hrs

0 / 0 / 1a

0 / 0 / 1a

0 / 0 / 0

0 / 0 / 0

7 days

0 / 0 /0f

0 / 0 /0f

0 / 0 / 0

-

Average 24h, 72h

0.0 /0.33/ 1.7

0.33/ 0.0 /1.7

0.0 /0.33/ 1.0

0.66 / 0.0 / 1.0

Reversibility*)

c.

c.

c. 

c.

Average time (unit) for reversion

7 days

7 days

 72 h

72 h

 

*) Reversibility: c. = completely reversible;n.c.= not completely reversible; n. = not reversible

a = skin appeared dry

f = flaking skin

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information The test chemical was considered as slightly irritating and no classification according to EU criteria is required. Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions of this study, the test item was slightly irritant when applied topically to rabbits. However, according to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), the test item reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda should not be classified as irritating to the skin.
Executive summary:

 In a primary dermal irritation study (1994), New Zealand Albino rabbits (3 animals) were dermally exposed to 0.5 g of undiluted test article. Intact and abraded test sites were covered with an occlusive dressing for 4 hours. Skin sites were then scored for erythema and oedema 3 min, 1 hour, 4, 24, 48, 72 hours and day 7 after patch removal. Irritation was scored by the method of Draize.

 

Erythema, absent at 3 minutes post dose, was absent to slight at one and four hours. At 24 and 48 hours after patch removal, erythema was absent to well defined. At 72 hours erythema was absent to slight and absent on day 7. Edema, absent at 3 minutes post dose, was absent to slight at one and four hours. At 24 hours after patch removal, edema was absent to well defined. Edema was absent to slight at 48 hours and absent at 72 hours and on day 7.

Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.33 and 1.7 for erythema and 0.0, 0.33 and 1.0 for edema. Similar effects were observed with abraded skin. The modified primary irritation index is 1.17.

 

Under the experimental conditions of this study, the test item was slightly irritant when applied topically to rabbits. Based on these results, the test item reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda is not classified as irritating to the skin according to Annex VI of the Directive 67/548/CEE and to EU Regulation 1272/2008 (CLP).