Registration Dossier

Administrative data

Description of key information

After single occlusive exposure of intact as well as abraded clipped skin for 24 hours with 500 mg of moistened test material per site none of 6 animals showed irritation reactions. Neither erythemas nor edemas were observed at any treated site. 
The instillation of 100 mg of the solid analogous substance produced positive effects in the conjunctivae of the 3 animals 1 and 24 hours after treatment. The test article was regarded as a mild irritant to the rabbit eye but the effects were not sufficient for classification.

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: method not exactly as in standard, no GLP; short report with limited data
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
intact an abraded skin; 6 Animals; evaluation at 24 and 72 hours only
GLP compliance:
no
Remarks:
predates GLP regulation
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
No data
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
500 mg per patch
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 1 square inch per patch
- Type of wrap if used: the gauze patches were held in place by a rubberized cloth.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to US CFR title 16, section 1500.41; similar to Draize system.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals showed identical reactions
Time point:
other: 24 h and 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals showed identical reactions
Time point:
other: 24 h and 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24h and 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No irritation
Other effects:
none
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material did not induce skin irritation.
Executive summary:

After single occlusive exposure of intact as well as abraded clipped skin for 24 hours with 500 mg of moistened test material per site none of 6 animals showed irritation reactions. Neither erythema nor edema were observed at any treated site.

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Short report, no GLP
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Remarks:
pre-dates GLP regulation
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Morton commercial rabbits, Parsonage farm, Stansted, UK
- Age at study initiation: 12 to 14 weeks
- Weight at study initiation: 2,44 to 2,7 kg
- Housing: single, grid floor cages
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum):ad lib.
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 21
- Humidity (%): 48 to 62
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10/ 14
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 24 h after instillation

SCORING SYSTEM: acc. to Draize (1949)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hr
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hr
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hr
Score:
0
Max. score:
0
Irritant / corrosive response data:
Conjunctival irritation, identified by moderate redness, slight to moderate swelling and discharge, was noted in the 3 treated animals one hour after treatment. At the 24 hour observation all 3 rabbits showed moderate redness of the conjunctival membranes. The conjunctival irritation regressed and all eyes appeared normal on day 7.
No corneal opacity or iridtal inflarnmation was noted during the study period.
The hair adjacent to the eye was stained brown by the test article.
Interpretation of results:
not irritating
Remarks:
Migrated information slight effects not sufficient for classification Criteria used for interpretation of results: EU
Conclusions:
The test material was a mild irritant to the rabbit eye.
Executive summary:

A study was performed to assess the irritant effects of the test material on the eye of the New Zealand White rabbit. The protocol was designed to meet the requirements of Annex Vof the EEC Council Directive 79/831/EEC, the Organisatfon for Economic Co-operation and Development (OECD) and the HSE Approved Code of Practice Notification of New Substances Regulations 1982.

The instillation of 100 mg of solid Brown HH 469 produced positive eye effects in the conjunctivae of the 3 animals one and 24 hours after treatment. The test article was regarded as a mild irritant to the rabbit eye.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No irritant effects were observed after dermal application of the test item for 24 hours. Ocular application produced slight transient irritation of the conjunctivae. Recovery was achieved within 2 days. Effects were not sufficient for classification.


Justification for selection of skin irritation / corrosion endpoint:
target substance tested

Justification for selection of eye irritation endpoint:
sole valid study

Justification for classification or non-classification

Not classified.

Classification is not needed as the criteria are not fulfilled, neither after dermal nor after ocular treatment. The slight ocular effects were not sufficient for classification.