Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
MSDS RHODOCAL®CA/70
Author:
Rhodia
Year:
1998
Bibliographic source:
Product Safety Labs

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium dodecylbenzenesulphonate
EC Number:
247-557-8
EC Name:
Calcium dodecylbenzenesulphonate
Cas Number:
26264-06-2
Molecular formula:
C36H58CaO6S2
IUPAC Name:
calcium dodecylbenzenesulphonate
Details on test material:
(Benzenesulfonic acid, dodecyl-,calcium salt), purity 69-71%.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.6-3.5 kg
- Housing: individual cages, identified with ear tags
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiat ad libitum, 15 g/day
- Water (e.g. ad libitum): deionized water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 degree C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12 hrs

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 hrs
Observation period:
Observations were made at 30-60 minutes, and 24, 48, and 72 hrs after end of exposure. If adverse effects had not resolved by the 72 hr observation, additional observations were made at 7, 14, and 21 days after end of exposure.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal trunk area
- % coverage: 2.5 x 2.5 cm area
- Type of wrap if used: cellulose bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): removed with lukewarm water
- Time after start of exposure: 4 hrs

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Though erythema cleared by 7 days, it reappeared at 14 days.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.8
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
From 1 to 72 hrs after end of exposure , animals showed mild to severe erythema, and mild to moderate edema. At the 7 day observation, there was on edema or erythema. However, at the 14 day observation, there was mild to moderate erythema, and the skin was raised, inflexible, and dry. At the 21 day oberservation, there was thickening of the epidermis, but a clearing of the erythema.
Other effects:
Microscopic examination showed hardening of the skin, hyperkeratosis, and misalignment with nearby skin.

Any other information on results incl. tables

Skin Irritation in Rabbits

Animal

Observation

Erythema and Scabbing

Edema

1

0.5-1 hr

1

3

24 hrs

2

2

48 hrs

2

1

72 hrs

3

1

7 days

0

0

14 days

1

0

21 days

Clearing of thickening and redness

-

2

0.5-1 hr

1

3

24 hrs

2

2

48 hrs

3

2

72 hrs

3

2

7 days

0

0

14 days

2

0

21 days

Clearing of thickening and redness

-

3

0.5-1 hr

2

3

24 hrs

3

2

48 hrs

3

2

72 hrs

3

2

7 days

0

0

14 days

3

0

21 days

Clearing of thickening and redness

 

 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test substance is irritating to skin according to the DSD and CLP.
Executive summary:

Three female rabbits were exposed to 0.5 ml of test substance on the dorsal area of the trunk for four hours. After four hours, the test substance was removed by washing with lukewarm water. Observations for erythema and edema were made 0.5 -1, 24, 48, and 72 hrs. Since adverse effects were not fully resolved by the 72 hr observation, further observations were made at 7, 14, and 21 days. Mild to moderately severe edema and erythema were noted at the 1, 24, 48, and 72 hr observations. Erythema and edema cleared by the 7 day observation, but the erythema returned by the 14 day observation. This was clearing by the 21 day observation. The test substance is classified as a Category 2 irritant according to EU DSD and CLP guidelines.

Categories Display