Registration Dossier

Administrative data

Description of key information

The substance is mildly irritating to skin and minimally irritating to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion, other
Remarks:
Existing in vivo study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 June to 27 June 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD Guideline 404 (1992) and according to GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
- Name of test material (as cited in study report): SER-AD FX 511
- Physical state: liquid (colourless, slightly viscous)
- Analytical purity: no data; the purity of the test material was the responsibility of the sponsor
- Storage condition of test material: room temperature
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 w
- Weight at study initiation: 2.62 to 2.73 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 47-68
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

Type of coverage:
occlusive
Preparation of test site:
other: clipped
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 h
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100%
- Type of wrap if used: elasticated corset (TUBIGRIP) wrapped around the trunk

REMOVAL OF TEST SUBSTANCE: yes, by gentle sawbbing with cotton wool soaked in 74% Industrial Methylated Spirits
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize J.H. (1977)
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h mean values
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 72, 48 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Very slight erythema was observed in most animals, 1, 24, 48 and 72 h post-treatment. Very slight edema was noted in two animals 24 h after exposure of the substance on the skin, which only in 1 animals for 72 h. Desquamation was seen in one animal at 48 h, and in 2 at 72 h. All skin reactions disappeared within the 7 day observation period.
Other effects:
No other effects were noted

More detailed irritation scoring can be found in the attached document below.

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not a skin irritant.
Executive summary:

In this dermal irritation study, 3 young adult New Zealand rabbits, 2 males and 1 female, were exposedviathe dermal route to 0.5 ml of SER-AD FX 511 per animal. The test material was applied as a aliquid for 4 hours to a 2.5x 2.5cm of the body surface area of test animals. Animals then were observed for 7 days. Irritation was scored using the Draize scheme. Very slight erythema was observed in most animals, 1, 24, 48 and 72 h post-treatment. Very slight edema was noted in two animals 24 h after exposure of the substance on the skin, which only in 1 animals for 72 h. Desquamation was seen in one animal at 48 h, and in 2 at 72 h. All skin reactions disappeared within the 7 day observation period. In this study, SER-AD FX 511 was not a dermal irritant. On the basis of this study, SER-AD FX 511 does not warrant classification as being irritating to the skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The substance is mildly irritating to skin and minimally irritating to the eye in reliable in vivo studies.


Justification for selection of skin irritation / corrosion endpoint:
Only one study available. The study is Klimisch 1.

Justification for selection of eye irritation endpoint:
Only one study available. The study is Klimisch 1.

Justification for classification or non-classification

The substance does not cause skin irritation and the degree of eye irritancy is insufficient to meet the classification criteria. Hence it is not classified for skin or eye irritancy.