Registration Dossier

Administrative data

Description of key information

Testing for skin irritation has proven negative, due to the nature of the substance it is scientifically unjustifiable to perform an eye irritation study 

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Compliant
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Ltd., Biceseter
- Age at study initiation: 10 - 11 weeks
- Weight at study initiation: 2.1 - 2.5 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): ad libitum, Global Diet 2930C
- Water (e.g. ad libitum): ad libitum, mains drinking water
- Acclimation period: 7 to 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 52 - 57
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 hour cycle

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g/rabbit
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal flank area
- % coverage:
- Type of wrap if used: 2.5cm square gauze patch, secured using elastic compression tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize System
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible within: 24 hrs
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible within: 24hrs
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritation or corrosive effects seen

Table1Individual dermal reactions

Dermal reaction

Observation Time

Individual Scores – Rabbit Number, Sex, Initial Body weight and Final Body Weight

Total

 

25M
(2.1 – 2.2 kg)

26M
(2.5 – 2.7 kg)

27M
(2.5 – 2.7 kg)

Erythema/Eschar Formation

Imm

0

N/A

N/A

N/A

 

1 Hour

0

0

0

(0)

 

24 Hours

0

0

0

0

 

48 Hours

0

0

0

(0)

 

72 Hours

0

0

0

0

 

Oedema Formation

Imm

0

N/A

N/A

N/A

 

1 Hour

0

0

0

(0)

 

24 Hours

0

0

0

0

 

48 Hours

0

0

0

(0)

 

72 Hours

0

0

0

0

 

Sum of 24 and 72 hour Readings (S)

:

0

 

Primary Irritation Index (S/6)

:

0/6 = 0

 

Classification

:

NON-IRRITANT

 

 

( ) = total values not used for calculation of primary irritation index
N/A = not applicable

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance produced a primary skin irritation index of 0.0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
Executive summary:

As the test material did not produce positive criteria for irritation or corrosiveness in any rabbit according to the EEC labelling regulations and was classified as non-irritant to rabbit skin. No symbol or risk phrases are therefore required.

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 adverse effect observed (not irritating)

Additional information

Although negative results have only been obtained for skin, inhalation exposures using the nose only route produce simultaneous heavy exposures to the eyes, other fibres similar to this one have been used in long term inhalation tests during which no reports of excess irritation exist. Animals exposed by inhalation similarly show no evidence of respiratory tract irritation, although the normal physiological response (macrophage accumulation) occurs. This is regarded as a physiological rather than a pathological response.

Screening at manufacturers’ plants in the UK on other fibrous materials has failed to show any human cases of skin conditions related to fibre exposure, the study report is detailed in section 7.10.1. Magnesium Aluminium Silicate and Sodium Magnesium Silicate caused minimal eye irritation in a Draize eye irritation test (Elmore et al. 2003 - Elmore AR; Cosmetic Ingredient Review Expert Panel. Int J Toxicol. 2003;22 Suppl 1:37-102.). While most silicates used in cosmetics have not (for ethical reasons) been tested for eye irritation they are approved for use in cosmetics.

Justification for classification or non-classification

negative results in skin irritation studies in animals result in non-classification for irritancy and corrosion