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Description of key information

Eye and skin irritation tests.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

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:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted prior to establishment of international guidelines and good laboratory practices. It used a micornized from of the commercial product. Mirconization may impact (e.g. increase) the potential for toxicity.
Principles of method if other than guideline:
Based on U.S. Federal Hazardous Substances Act for determination of "primary" skin irritation.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
other: all clipped; 3/6 abraded
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
500 mg/rabbit
Duration of treatment / exposure:
24 hr
Observation period:
up to 72 hr
Number of animals:
3M/3F
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hr
Score:
0.05
Max. score:
0.2
Reversibility:
no data
Irritant / corrosive response data:
At 24 hr post-dosing, no positive scores were reported for erythema or edema. One of the 6 rabbits had very slight erythema at an abraded site 72 post-dosing. All other sites/rabbits had no redness or swelling at 72 hours.
Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: expert judgment
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
Remarks:
other: U.S. Federal Hazardous Substances Act
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1974
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study was performed using a micronized version of the commercial product as the test article. Micronization may impact (e.g. increase) the potential for toxicity. The results of this study markedly contrast those of a later guideline/GLP study which found no evidence of eye irritation.
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
3M/3F rabbits were used. Wt=2675 to 3240 g. Food and water available ad libitum. Eyes examined prior to study initiation. Onlty those with normal eyes were used int the study.
Vehicle:
unchanged (no vehicle)
Controls:
other: each animal served as its own control
Amount / concentration applied:
100 mg/right eye of each rabbit
Duration of treatment / exposure:
Whether eyes were rinsed is not indicated in the study report.
Observation period (in vivo):
24, 48 and 72 and at 7 days post-treatment. Sodium fluorescein applied at 72 hrs.
Number of animals or in vitro replicates:
3M/3F
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hr, 7 days
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: all scores at all timepoints = 0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hr
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hr
Remarks on result:
other: all scores 0 at 48 hr reading
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hr
Score:
11.4
Max. score:
3
Reversibility:
fully reversible within: 7 days post-dosing
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hr
Score:
3.2
Max. score:
2
Reversibility:
fully reversible within: 7 days post-dosing
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hr
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days post-dosing
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
0
Reversibility:
other: not applicable

The corneas of all animals appeared normal at all time points. The iris of all animals appeared normal at all time points except in one animal at 24 hr post-dosing which had iridal irritation.

Moderate conjunctival redness was noted in 5/6 animals at 24 -hrs post-dosing whereas 1/6 animals had marked conjuctival redness at this timepoint. At 48 hrs, half of the animals had slight conjunctival redness and half had moderate. At 72 hr, 2/6 animals had normal conjunctiva, 3 had slight redness and 1 had moderate redness. By Day 7, all animals had normal scores for redness.

Conjunctival chemosis at 24 hr was very slight (3/6), slight (1/6) and moderate (2/6). At 48 hrs, it was normal in 5/6 rabbits and very slight in 1/6 whereas at 72 hrs 4/6 were normal and 2/6 had very slight chemosis. All scores for chemosis were normal at 7 days post-dosing.

Conjunctival discharge was noted at 24 hrs: very slight (2/6), slight (1/6), moderate (1/6) and marked (2/6). No discharge was noted at 48 or 72 hrs or 7 days post-dosing.

Interpretation of results:
Category 2B (mildly irritating to eyes)
Remarks:
Migrated information Criteria used for interpretation of results: GHS
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 11-14, 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to accepted guideline and Good Laboratory Practices.
Qualifier:
according to guideline
Guideline:
other: EPA 560/6-82-001
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Adult male and female rabbits were obtained from Sgarlat's Rabbitry, Harvey's Lake, PA. Housed individually in temperature and humidity contolled room with a 12/12 hr light/dark cycle. Wayne Rabbit Ration and water were provided ad libitum.
Vehicle:
unchanged (no vehicle)
Controls:
other: each animal (left eye) served as its own control
Amount / concentration applied:
One application of 100 mg to the right eye.
Duration of treatment / exposure:
72 hrs
Observation period (in vivo):
1, 24, 48, 72 hours.
Number of animals or in vitro replicates:
3 M and 3 F
Details on study design:
Animals were examined 24 hr prior to dosing. Any showing eye irritation/damage were not utilized in the study. The test substance was placed in the conjunctival sac of the right eye of each animal. The lids were gently held together for 1 second to limit loss of the material. The left eye served at the control.

Grading was according to the method of Draize 1965, Draize 1959, and Draize et al. 1944.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 1 hr post-dosing
Score:
0.66
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: 4/6 rabbits had scores of 1 at 1 hr post-dosing
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24 h
Score:
0.16
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: 1/6 rabbits had score of 1 at 24 hr post-dosing
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Other effects:
none
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Saytex RB-49 was not an eye irritant.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Eye and skin irritation tests have demonstrated the substance is not an irritant.

Justification for classification or non-classification

Based on the available study data classification is not required in accordance with Regulation 1272/2008 (CLP)