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Description of key information

Based on the results of the skin and eye irritation studies, the test substance can be regarded to be irritating to skin and to cause irreversible effects on the eye.

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:
17 to 24 July 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, U.K
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.25 to 2.53 kg
- Housing: single
- Diet: Rabbit Diet, Special Diet Services Limited, Witham, Essex, UK ad libitum
- Water: tap water was available for ad libitum consultion
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-22
- Humidity (%): 60-68
- Air changes (per hr): ca 15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm*2.5 cm
- Type of wrap if used: adhesive strapping (SLEEK), covered by an elasticated corset (TUBIGRIP)


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


SCORING SYSTEM: according to Draize

Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 h
Score:
2.7 - 3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Very slight erythema and oedema were noted at one test site one hour after removal of the Patches. The other two test sites appeared at this time. Well-defined erythema with moderate to slight oedema developed at all test sites at subsequent 24, 48 and 72-hour observations. No erythema or oedema was noted on day 7 but all test sites showed hyperkeratinisation and desquamation at this time.
Other effects:
Bright orange stains were noted at the treatment sites throughout the studyt which did not affect assessment of irritation.
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study, the test substance can be regarded as 'irritating to the skin'
Executive summary:

A study for irritant potential on the rabbit's skin was conducted with Yoracryl Yellow RL Liq 100 in accordance with the OECD Guideline for Testing of Chemicals No. 404. With respect to the OECD Interpretation Guides results were interpreted in conjunction with the nature, intensity, and reversibility of the responses observed.

Based on the results the test substance can be regarded as 'irritating to the skin'.

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:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, U.K
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.25 to 2.53 kg
- Housing: single
- Diet: Rabbit Diet, Special Diet Services Limited, Witham, Essex, UK ad libitum
- Water: tap water was available for ad libitum consultion
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-18
- Humidity (%): 68
- Air changes (per hr): ca 15
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
1 h
Observation period (in vivo):
1 h
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Animal was killed immediately after the 1-hour observation for animal welfare


SCORING SYSTEM: according to Draize
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 h
Score:
4
Max. score:
4
Reversibility:
not specified
Irritant / corrosive response data:
The conjunctival and nictitating membranes were very pale in appearance approximately two minutes after treatment and a cloudiness of the cornea was also noted, which became more dense until approx. 10 min. after dosing; the pupil was only just visible.
Approx. 35 min. after treatment severe swelling of the conjuntivae with complete closure of the eyelids was observed; the conjunctival/nictitating membranes were pale, the cornea densely clouded over the complete cornea.
One hour after treatment, the corneal surface was completely opaque, making it impossible to evaluate the iridal response. The conjunctival/nictitating membranes were pale with severe swelling of the conjuntivae causing complete closure of the eyelids.
Other effects:
All structures of the eye were orange discolored.
The animal was killed for animal welfare reasons after the one hour observations. No further rabbits were treated.
Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results the test substance can be regarded to cause irreversible effects on the eye
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification