Calcium 1,4-bis(2-ethylhexyl) bis(2-sulphosuccinate)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to internationally accepted test guidelines. As the test material also contains ethanol and methanol, these ingredients may have potential influence on the irritation score.

Justification for type of information:

No data are available for the registered substance, however data are available for the corresponding sodium salt of the substance, docusate sodium (CAS 577-11-7). These data are used for read-across to the registered substance calcium docusate (CAS 128 -49 -4). The presence of either of the counterions sodium or calcium is not considered to have an impact on the toxicity. It is therefore considered justified to use the data of the sodium salt for read across to the calcium salt of docusate.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Docusate sodium

EC Number:

209-406-4

EC Name:

Docusate sodium

Cas Number:

577-11-7

Molecular formula:

C20H38O7S.Na

IUPAC Name:

sodium 1,4-bis[(2-ethylhexyl)oxy]-1,4-dioxobutane-2-sulfonate

Constituent 2

Reference substance name:

formulated product containing 70% docusate sodium

IUPAC Name:

formulated product containing 70% docusate sodium

Details on test material:

- Name of test material (as cited in study report): MARLINAT DF 8
- Physical state: liquid, clear
- Analytical purity: 70% Docusate sodium
70% Docusate sodium
15% Ethanol (diluted with 5% Methanol)
15% Water

Test animals

Species:

rabbit

Strain:

other: White Russian, Chbb-SPF

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa.Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2,2 - 2,3kg
- Housing: separate in stainless steel cages
- Diet : KZ Alleindiät für Kaninchen, Ssniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water : public supply, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20°C +-1°C
- Humidity:60% +-5%
- Air changes (per hr): 15 air replacements/hour
- Photoperiod (hrs dark / hrs light): 12 /12

IN-LIFE DATES: From: 1988-02-23 To: 1988-03-08

Test system

Type of coverage:

occlusive

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 undiluted
- Concentration (if solution): 70% Docusate sodium

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours; 6, 8, 10 and 14 days

Number of animals:

3 male

Details on study design:

TEST SITE
- Area of exposure: 6 cm3
- % coverage:
- Type of wrap if used: polyethylene film (6X6 cm) which was secured in position by means of
an elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD 404: See Table 1

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1h, 24h, 48h, 72h

Score:

7.8

Max. score:

8

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Score = sum of erythema & oedema

Irritant / corrosive response data:

Stronly irritating

Any other information on results incl. tables

Table 1. Dermal irritation scores and observations

Animal No. (Ear No.)	Sex	Response	1 hour	24 hours	48 hours	72 hours	6 days	8 days	10 days	14 days
1 (51227)	M	Erythema	3 x	4 xV	4 xVP	4 xVP	WScp	WScp	WScp	Na
		Oedema	4	4	4	4
2 (51231)	M	Erythema	3 x	4 xV	4 xVP	4 xVP	WScp	WScp	Scp	Scp iA
		Oedema	4	4	4	4
3 (51371)	M	Erythema	3 x	4 xV	4 xVP	4 xVP	WScp	WScp	Scp	Scp abgelöst Na

x= yellow coloration in applicated area (Gelbfärbung im Applikationsbereich)

V= hardening in applicated area(Verhärtung im Applikationsbereich)

W= wavily, can be imprinted (Wellig, last sich eindrücken)

P= perkamen-like (pergamentartig)

Scp=crust (Schorfplatte)

blNa= bloody scars (bluttige Narben)

Na=Scars (Narben)

Ri= Cracked (rissig)

iA= In replacement (in Ablösung)

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information Criteria used for interpretation of results: other: EU GHS

Conclusions:

Irriation index = 7.8/8.

Executive summary:

No data are available for the registered substance, however data are available for the corresponding sodium salt of the substance, docusate sodium (CAS 577-11-7). These data are used for read-across to the registered substance calcium docusate (CAS 128-49-4). The presence of either of the counterions sodium or calcium is not considered to have an impact on the toxicity. It is therefore considered justified to use the data of the sodium salt for read across to the calcium salt of docusate.

A volume of 0.5 mL Docusate sodium (70% solution in ethanol/methanol and water) was applied according to OECD 404 on 6 cm2 shaved skin of 3 male rabbits by occlusive application. After this period, the skin area was washed with warm water and observed after 1, 24, 48, 72 hours and 6, 8, 10 and 14 days. The results showed that there was an irritation index of 7.8/8 over the 1 -72 hour period and effects were still visible at 14 days.