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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 based on grouping of substances (category approach)
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:
Data has been read across from a structurally similar substance in a category approach. See further discussion in the read across justification attached.
Cross-reference
Reason / purpose:
read-across: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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
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:

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.