Registration Dossier

Administrative data

Description of key information

Skin: The test substance was not irritating to the rabbits' skin under the test conditions chosen.
Eye: The test substance was not irritation to the rabbits' eye under the test conditions chosen.

 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1964
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: the test compound was received from Lucidol Division, Wallace and Tiernan, Inc.
- Weight at study initiation: 1729 to 2504 g
- Housing: All animals were placed in holders designed to immobilize the animal
Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied:0.5 mL/rabbit
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
twelve albino rabbits (two groups of 6 animals)
Details on study design:
TEST SITE
- Area of exposure: Approximately one inch square on each site of the back of the animals.
- Type of wrap if used: The rabbits were further prepared following application by placing a piece of rubber dam 2x2 inches over each area of application. The damming was held in place with adhesive tape and the entire trunk of each animal wrapped with rubberized cloth bandage to hold the patches in place and retard the evaporation of volatile substance.

REMOVAL OF TEST SUBSTANCE
- Washing: The back of each rabbit was washed with lukewarm water
- Time after start of exposure: 24 hours

READINGS: The areas of compound application were exermined after 24 hours and 72 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
0
Max. score:
4
Interpretation of results:
GHS criteria not met
Conclusions:
On the basis of the results obtained in this study, the test substance does not possess any primary irritating properties to the skin of albino rabbits under the test conditions chosen.
Executive summary:

The test substance was applied once only at a total volume of 0.5 mL/rabbit to the prepared dermal surface of the back of albino rabbits. On the basis of the results obtained in this study, the test substance dies not possess any primary irritating properties to the skin of this species under the test conditions chosen (mean erythema score and mean edema score = 0).

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
All housing and care were based on the standars recommended by the Guide for the Care and Use of Laboratory Animals.
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Adult, New Zealand White rabbits were received at SLI from Myrtle's Rabbitry, Thompson Station, TN.
- Animal Selection: The animals for study were arbitrarily selected from healthy stock animals to avoid potential bias. All animals received a detailed pretest observation prior to dosing. Only healthy animals were chosen for study use. Females were nulliparous and nonpregnant.
- Housing: The animals were housed individually in suspended stainless steel cages.
- Identification: Plastic ear tags displaying unique identification numbers were used to individually identify the animals.
- Diet: PMI Certified Rabbit Chow #5322 (Purina Mills, Inc.) was provided ad libitum to the animals throughout the study.
- Water: Municipal tap water treated by reverse osmosis was available ad libitum throughout the study. the purified water was supplied by an automatic watering system.
- Acclimation period: Animals were acclimated for a minimum of five days to the laboratory conditions. The animals were observed daily for overt physical or behavioral abnormalities, general health/moribundity and mortality.

ENVIRONMENTAL CONDITIONS
- Temperature: ca. 16.7 - 18.9 °C
- Humidity: 52 - 64 %:
- Air changes: 10 - 15 per hour
- Photoperiod: 12-hour light/12-hour dark
Vehicle:
unchanged (no vehicle)
Controls:
other: the other eye, remaining untreated, serves as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration: 100 %
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
1, 24, 48 and 72 hours after dosing
Number of animals or in vitro replicates:
6 (2 males, 4 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: At the 24 hour scoring interval, any residual test acticle was gently rinsed from the eye at this time using physiological saline.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24,48,72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24,48,72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h,48,72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24,48,72 h
Score:
0.4
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this test, the test substance is considered to be a non irritant to the ocular tissue of the rabbit.
Executive summary:

In this study, the potential irritant and/or corrosive effects of the test substance were evaluated on the eyes of New Zealand White rabbits. Each of six rabbits received a 0.1 mL dose of the test article in the conjunctival sac of the right eye. The contralateral eye of each animal remained untreated and served as a control. Test and control eyes were examined for signs of irritation for up to 72 hours following dosing. Exposure of the test article produced conjunctivitis (redness and/or swelling and/or discharge) in 6/6 test eyes at the 1 hour scoring interval. The conjunctival irritation resolved completely in all animals by the 72 hour scoring interval. A mean conjunctivae score (24,48,72h) of 0.4 was determined. The observed mean scores for cornea, iris and chemosis were 0. Under the conditions of this test, the test substance is considered to be a non irritant to the ocular tissue of the rabbit.

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation study:

In a skin irritation study, the test substance was applied once only at a total volume of 0.5 mL/rabbit to the prepared dermal surface of the back of albino rabbits (International Research & Development Corporation 1964). On the basis of the results obtained in this study, the test substance dies not possess any primary irritating properties to the skin of this species under the test conditions chosen (mean erythema score and mean edema score = 0).

Eye irritation study:

In a eye irritation study, the potential irritant and/or corrosive effects of the test substance were evaluated on the eyes of New Zealand White rabbits (Springborn Laboratories 1996, 3255.103). Each of six rabbits received a 0.1 mL dose of the test article in the conjunctival sac of the right eye. The contralateral eye of each animal remained untreated and served as a control. Test and control eyes were examined for signs of irritation for up to 72 hours following dosing. Exposure of the test article produced conjunctivitis (redness and/or swelling and/or discharge) in 6/6 test eyes at the 1 hour scoring interval. The conjunctival irritation resolved completely in all animals by the 72 hour scoring interval. A mean conjunctivae score (24,48,72h) of 0.4 was determined. The observed mean scores for cornea, iris and chemosis were 0. Under the conditions of this test, the test substance is considered to be a non irritant to the ocular tissue of the rabbit.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008 (CLP). As a result the substance is not considered to be classified for skin and eye irritation under Regulation (EC) No 1272/2008.