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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
March-April 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed in 1991 in accordance with EC methods and GLP compliance. Diluted material was used, representing the commercially supplied product.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

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

Test material

Constituent 1
Reference substance name:
β-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs., disodium salts
EC Number:
290-476-8
EC Name:
β-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs., disodium salts
Cas Number:
90170-43-7
Test material form:
other: aqueous solution

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.09-2.73 kg
- Gender: female
- Housing: individually in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-22
- Humidity (%): 47-56
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: March 1991

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
A quantity of 0.5 ml of the test material, was introduced under a 2.5 cm x 2.5 cm gauze patch and placed in position on the shorn skin.
The patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm).
To prevent the animals interfering 'with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period.
Duration of treatment / exposure:
Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in diethyl ether.
Observation period:
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to Draize J.H. (1959).
Number of animals:
Three
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cmgauze patch
- Type of wrap if used: patch secured with strip of surgical adhesive tape (BlendermTM, approx. 2.5 cm x 4 cm) - Trunk of the animals wrapped in an elasticated corset (TubigripTM)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material removed by gentle swabbing with cotton wool soaked in diethyl ether
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Other effects:
No other observed adverse effects

Any other information on results incl. tables

Very slight erythema was noted at all treated skin sites one and 24 hours after treatment and persisted at two treated skin sites at the 48 and 72hour observations. The reaction extended beyond one treatment site.

Very slight or slight oedema was noted at all treated skin sites one hour after patch removal.

Very slight oedema continued to be noted at onetreated skin site at the 24-hour observation.

Desquamation was noted at two treated skin sites at the 7-day observation.

No other adverse reactions were noted during the study.

Summary table:

Skin reaction

Observation time

Individual scores

Female 1

Female 2

Female 3

Erythema/eschar

1 hour

1

1

1*

24 hours

1

1

1

48 hours

1

1

0

72 hours

1

1

0

7 days

0**

0**

0

Oedema

1 hour

1

2

1

24 hours

0

1

0

48 hours

0

0

0

72 hours

0

0

0

7 days

0

0

0

* Reaction extended beyond treatment site

** Desquamation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Only slight transitory effects noted, not requiring classification.
Executive summary:

In an OECD TG 404 and GLP-compliant study in three rabbits, disodium cocoiminopropionate as an aqueous solution at 30% produced a primary irritation index of 1.0 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted . The test material did not produce positive criteria in any rabbit according to the EC classification requirements