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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
25 May 1995 - 27 July 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP and OECD test guideline-compliant study performed on an analogue substance (for justification of read-across between Lauramidopropylhydroxysultaine and cocamidopropylhydroxysultaine, please refer to corresponding assessment report in Section 13).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: viscous yellowish liquid
Details on test material:
- Name of test material (as cited in study report): BETADET SHR
- Substance type: liquid
- Physical state: viscous yellowish liquid
- Analytical purity: 41.5% CAS 68139-30-0 (data not included in study report)
- Lot/batch No.: 7049
- Storage condition of test material: at room temperature, in the dark
- Other: test material received in a glass recipient at test facility on April 26th, 1995 - Test substance pH = 7.48

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: accredited supplier
- Gender: male
- Age upon arrival at test facility: approx. 9-10 weeks
- Weight at study initiation: 2.3 - 2.4 kg
- Housing: individually in stainless steel cages (48 x 59 x 37 cm) with grilled floor
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 50-85
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 30 May 1995 To: 16 June 1995

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours after the end of exposure period (examinations at 60 min, 24, 48 and 72 h)
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: substance placed on 2.5 x 2.5 cm surgical gauze, patch held close to the skin using adhesive tape strips, strip of gauze wrapped around trunk of the animal using additional adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): once patch removed, remainder of product eliminated with water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.22
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
See table below

Any other information on results incl. tables

Animal number

Erythema / Eschar

Edema

60 min

24 h

48 h

72 h

Individual score*

60 min

24 h

48 h

72 h

Individual score*

146

1

0

0

0

0

0

0

0

0

0

912

1

0

0

0

0

0

0

0

0

0

913

1

1

1

0

0.67

0

0

0

0

0

 

Mean score

0.22

Mean score

0

* For the 24, 48 and 72 h timepoints

Details of skin irritation scores (according to Draize)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Cocamidopropyl hydroxysultaine, as a 41.5% solution, is not considered a skin irritant.
Executive summary:

Cocamidopropyl hydroxysultaine, as a 41.5% solution, has been tested for acute skin irritation on 3 male New Zealand White rabbits, in accordance with OECD test guideline 404, and in compliance with Good Laboratory Practice.

The test article was applied as such in a single dermal dose of 0.5 mL to a shaved 6 cm² area of the intact skin, for 4 hours under a semi-occlusive dressing. Cutaneous examinations were performed at 1, 24, 48 and 72 hours after the dressing removal.

One hour after dressing removal, very slight erythema (grade 1) was observed in all animals. At examinations carried out 24 and 48 h after dressing removal, only one animal showed very slight erythema (grade 1).

No cutaneous reactions were observed in any of the animals at 72 hours after dressing removal.

Mean scores for erythema and edema (24, 48 and 72 hours after treatment) were 0.22 and 0.00, respectively.

 

Based on these results, Cocamidopropyl hydroxysultaine, as a 41.5% solution, was not considered a skin irritant.