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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:
September 1989 - January 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Substance: CESIO 33. No data on batch no. and composition. Basic data given according to guidelines/standards.
Cross-reference
Reason / purpose:
reference to same study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
6 animals rather than 3 animals were used
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of the test compound in the report: CESIO 33
Name of the test compound: amines, tallow alkyl ethoxylates, 2EO
Appearance: brown liquid
Date of receipt: 11 October 1989
Storage: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2-3 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 13-21
- Humidity (%): 47-69
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 26 September 1989 To: 4 January 1990 (for all 17 compounds)

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 hours (Exposure of 3 min was also preformed but no data reported).
Observation period:
up to 14 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm gauze patch
- % coverage: not indicated
- Type of wrap if used: gauze patch was secured with surgical adhesive tape (2.5 x 4 cm); the trunk was wrapped in an
elasticated corset.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, by gently swabbing with cotton wool soaked in diethyl ether
- Time after start of exposure: immediately following patch removal


SCORING SYSTEM:
EVALUATION OF SKIN REACTIONS
Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar
formation (injuries in depth) 4

Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by
definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and
extending beyond area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
2.67
Max. score:
3
Reversibility:
not reversible
Remarks:
within 14 days
Remarks on result:
other: scar tissue in 5/6 animals
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
3.67
Max. score:
4
Reversibility:
not reversible
Remarks:
within 14 days
Remarks on result:
other: evaluation in 5/6 animals at day 7/14 not possible due to presence of other adverse dermal reactions
Irritant / corrosive response data:
Severe dermal responses were produced. The adverse skin reactions sometimes precluded accurate evaluation of erythema and
oedema. Very slight to well -defined erythema, haemorrhage of the dermal capillaries and slight to moderate oedema were noted
one hour after patch removal. The responses increased in severity and at subsequent observations were identified as well -
defined and moderate to severe oedema, haemorrhage of the dermal capillaries, blanching of the skin, a brown discolouration of theepidermis, scabbing, loss of skin flexibility, a straw-coloured crust (possible hyperkeratinisation), desquamation, thickening of the
skin, reduced re-growth of fur and glossy skin. Scar tissue, indicative of dermal corrosion was noted in five out of six rabbits.
Other effects:
No data.

Any other information on results incl. tables

Summary of dermal irritation (following 4-h application)

Animal no.

Effect

Hour

Days after application

Mean score erythema

(24/48/72 h)

Mean score oedema

(24/48/72 h)

1

1

2

3

7

14

25 M

Erythema

Oedema

2

2

3

4

2

4

?

?

?

?

?

?

2.5?

4?

28 F

Erythema

Oedema

2

2

3

4

3

3

?

?

?

?

0

?

3?

3.5?

31 M

Erythema

Oedema

2

3

3

4

3

4

3

3

?

?

?

?

3

3.67

33 M

Erythema

Oedema

2

2

3

4

3

4

3

3

?

?

?

?

3

3.67

73 M

Erythema

Oedema

2

2

2

4

2

4

2

3

?

?

?

0

2

3.67

134 F

Erythema

Oedema

1

2

2

4

3

3

?

?

?

?

?

?

2.5?

3.5?

Mean all animals

2.67?

3.67?

? Unable to evaluate degree of erythema or oedema due to presence of other adverse dermal reactions

At day 7: scabs, dry straw-coloured crust, sometimes flaking from the skin (possible hyperkeratinisation)

At day 14: desquamation, thickening of the skin, scabs, scar tissue, reduced re-growth of fur, skin glossy in appearance (keratinolysis)

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Remarks:
Migrated information
Conclusions:
The test material was considered to be corrosive (Category 1C) to the rabbit skin according to OECD-GHS. This was essentially
based on the formation of scar tissue, indicative of dermal corrosion, in 5 out of 6 rabbits.
Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irri tation/Corrosion" and Method B4 of the EC. A single

4 -hour, semi-occluded application of the test material to the intact skin of six rabbits produced severe dermal responses. Scar tissue, indicative of dermal corrosion was noted in 5 out of 6 rabbits 14 days after application. The test material was therefore classified as corrosive (Category 1C) to the rabbit skin, according to OECD/GHS criteria.