Registration Dossier

Administrative data

Description of key information

Slightly irritating to skin and severe ocular irritant and possibly corrosive.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: New Zealand Albino
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hour(s)
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- % coverage: 100 %
- Type of wrap if used: patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with destilled water
- Time after start of exposure: 4 hours


SCORING SYSTEM:

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
definiteraising) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Moderate oedema (raised approximately 1.0 mm) . . . . . . . . . . . . . 3
Severe oedema (raised more than 1.0 mm and
ex tending beyond area of exposure) . . . . . . . . . . . . . . . . . . . . . . . . 4

Irritation parameter Basis Time point Score
erythema score animal #1 D9878/M 1 hour 1
erythema score animal #1 D9878/M 24 hours 0
erythema score animal #1 D9878/M 48 hours 0
erythema score animal #1 D9878/M 72 hours 0
edema score animal #1 D9878/M 1 hour 0
edema score animal #1 D9878/M 24 hours 0
edema score animal #1 D9878/M 48 hours 0
edema score animal #1 D9878/M 72 hours 0
erythema score animal #2 D9879/M 1 hour 1
erythema score animal #2 D9879/M 24 hours 1
erythema score animal #2 D9879/M 48 hours 0
erythema score animal #2 D9879/M 72 hours 0
edema score animal #2 D9879/M 1 hour 0
edema score animal #2 D9879/M 24 hours 0
edema score animal #2 D9879/M 48 hours 0
edema score animal #2 D9879/M 72 hours 0
erythema score animal #3 D9880/M 1 hour 1
erythema score animal #3 D9880/M 24 hours 1
erythema score animal #3 D9880/M 48 hours 0
erythema score animal #3 D9880/M 72 hours 0
edema score animal #3 D9880/M 1 hour 0
edema score animal #3 D9880/M 24 hours 0
edema score animal #3 D9880/M 48 hours 0
edema score animal #3 D9880/M 72 hours 0

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test article is a mild irritant but not corrosive.
Executive summary:

Erythema, slight at 30 - 60 minutes after patch removal, was
absent to slight at 24 hours and absent at 48 and 72 hours. 
Edema, was absent at all observation intervals.  There were
no abnormal physical signs noted during the observation
period.Primary Irritation Index of 0.17 (mildly irritating)
when applied to the intact skin as a paste.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions
Qualifier:
according to
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
Amount applied: 0.1 ml
Number of animals or in vitro replicates:
9
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hour
Score:
20.333
Max. score:
27
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
50.333
Max. score:
57
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
50.333
Max. score:
57
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
39.333
Max. score:
47
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 7
Score:
15.333
Max. score:
36
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 14
Score:
6.666
Max. score:
10
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: day 21
Score:
6.666
Max. score:
10

Unwashed eyes:  Corneal opacity, noted in 6/6 eyes,
persisted to Day 21 in 3/6 eyes.  Iritis, noted in 6/6 eyes,
cleared by Day 7.  Conjunctival irritation, noted in 6/6
eyes, cleared by Day 14.

Washed eyes:  Corneal opacity, noted in 3/3 eyes, cleared by
Day 14.  Iritis, noted in 3/3 eyes, cleared by Day 7. 
Conjunctival irritation, noted in 3/3 eyes, cleared by Day
14.

Interpretation of results:
highly irritating
Remarks:
Migrated information
Conclusions:
Classification: irritating
Surfynol 104 Surfactant is an ocular irritant and possibly corrosive.
Executive summary:

Nine healthy New Zealand White rabbits, free from evidence
of ocular irritation and corneal abnormalities, were dosed. 
Surfynol 104 (0.1 ml) was placed into the conjunctival sac
of one eye of each rabbit.  Six eyes remained unwashed. 
Three eyes were washed with lukewarm water for one minute,
30 seconds postdose.  The eyes were examined and scored by
the Draize technique at one hour and at 24, 48, and 72 hours
postdose.  In order to determine reversibility, the eyes
were examined again on Days 7, 14, and 21.  Sodium
fluorescein was used to determine corneal effects following
the 24-hour scoring interval. There were no abnormal systemic signs noted during the observation period.

Surfvnol 104 Surfactant is an ocular irritant and possiblv corrosive.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Here is no data gap.

According to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Part 3 Chapter 3.2 and Chapter 3.3 it is classified to be irritating to eye.


Justification for selection of skin irritation / corrosion endpoint:
According to OECD 404, insoluble solid substances should be applied as paste, therefore this study is chosen, which meets the criteria set forth in Regulation EC No. 440/2008 for filling REACH endpoints. The data is generated in a reliable laboratory using established protocols.

Justification for selection of eye irritation endpoint:
Only one study available.

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

According to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Part 3 Chapter 3.2 and Chapter 3.3 it is classified to be irritating to eye.