Registration Dossier

Administrative data

Description of key information

Skin Irritation - Molyvan 855 is slightly irritating under the conditions of this study.
Eye Irritation - Molyvan 855 was found to be moderately irritating.
Respriratory Irritation - study not required

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: Study conducted similar to OECD Guideline under GLP conditions. Study report does not specifically identify test guideline followed, however, evaluation of the full study supports that the study is conducted similar to OECD test guidelines.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
Approved supplier

- Age at study initiation:
Young adult

- Weight at study initiation:
2.40 +/- 0.14 KG

- Housing:
All housing and care conformed to the standards established in "Guide for the care and Use of Laboratory Animals" DHEW Publications No. (NIH) 85-23.

- Diet (e.g. ad libitum):
Certified rabbit feed ad libitum

- Water (e.g. ad libitum):
Tap water ad libitum

- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
Room temperature

- Photoperiod (hrs dark / hrs light):
12 Hour light dark cycle maintained.
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
4.5, 28, 52 and 76 hours post-exposure
4, 7, 10 and 14 days post exposure
Number of animals:
6
Details on study design:
On the day prior to dosing, the back of each rabbit was clipped free of fur with electric clippers. During this procedure, care was taken to avoide accidental abrasion to the skin. On the day of dosing. a volume of 0.5 ml of the test article was applied to each of 2 test sites. Following application, each test site was occluded with a one-inch square gauze patch held in place with Blenderm(r) tape.

Four hours post-dose, the patches were removed. The exposure sites were gently wiped with clean gauze to remove as much non-absorbed test article as possible. One half hour after unwrapping, the exposure sites were examined and scored separately for both erythema and edema on a graded sc all of 0 to 4 in accordance with the Skin Reaction Code. The exposure sites were again examined and scored at 28, 52 and 76 hours post-dose. Any signs of irritation were noted and observations were made on day 4, 7, 10 and 14 or until all sites returned to normal. Any extraordinary finding. dermal or toxicological, were noted.

In evaluation the average irritation, scores for individual intact exposure sites were recorded separately for each of the scoring time intervals. Based on the 28, 52 and 76 hour observations, a total for erythema and eschar formation was added to a total for edema, then divided by 6 to yield individual animal score. The mean of the six scores was calculated and this score represents the mean primary score.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 76 hours post dosing
Score:
0.73
Max. score:
8
Reversibility:
fully reversible within: 7 days
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 76 hours post dosing
Score:
1
Max. score:
8
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 72 hours post dosing
Score:
1.2
Max. score:
8
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 72 hours post dosing
Score:
0.83
Max. score:
8
Irritation parameter:
overall irritation score
Basis:
animal #4
Time point:
other: 72 hours post dosing
Score:
0.67
Max. score:
8
Irritation parameter:
overall irritation score
Basis:
animal #5
Time point:
other: 72 hours post dosing
Score:
0.33
Max. score:
8
Irritation parameter:
overall irritation score
Basis:
animal #6
Time point:
other: 72 hours post dosing
Score:
0.33
Max. score:
8
Irritant / corrosive response data:
Slight erythema and eschar formation was the primary effect observed in animals up until 76 hours post dosing. Slight edema formation was observed in two animals post dosing up to 28 hours post dosing.
Other effects:
One animal died on day 8 and another on day 14. Prior to death of the above two animals, anorexia and diarrhea were observed. No lesions or abnormalities were noted in these animals at gross necropsy.
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Modification of J. Soc. Cosmet. Chem. Vol 13, No 6. 1962, p. 281 - 289
Conclusions:
Molyvan 855 is slightly irritating under the conditions of this study.
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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted similar to OECD Guideline under GLP conditions. Study report does not specifically identify test guideline followed, however, evaluation of the full study supports that the study is conducted similar to OECD test guidelines.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Principles of method if other than guideline:
Principles and Procedures for Evaluating the Toxicity of Household Substances.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Remarks:
undiluted 0.1 ml
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml undiluted
Duration of treatment / exposure:
one time administration
Observation period (in vivo):
1, 24, 48 and 72 hours and again at 4 and 7 days
Number of animals or in vitro replicates:
9 total
6 unwashed (test material only)
3 (test material washed 30 seconds after application with luke warm water)
Details on study design:
9 New Zealand White rabbits were administered 0.1 ml of the test substance in one eye of each rabbit. For six rabbits the treated eye remained unwashed and for the remaining 3 rabbits, the eye was washed 30 seconds post exposure with luke warm water. The other eye of each rabbit served as the control.

Irritation parameter:
maximum mean total score (MMTS)
Basis:
other: overall
Time point:
other: 72 hours
Score:
45
Max. score:
110
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hr
Score:
6.7
Remarks on result:
other: + or - 1.6 (no washout)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hrs
Score:
2.3
Remarks on result:
other: + or - 1.5 (no washout)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
0.3
Remarks on result:
other: + or - 0.8 (no washout)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: (no washout)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hr
Score:
4
Remarks on result:
other: + or - 2.0 (30 second washout)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
2
Remarks on result:
other: + or - 2.0 (30 second washout)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: (30 second washout)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: (30 second washout)
Irritant / corrosive response data:
The study report/author did not provide the MMTS, this was calculated based upon the results provided within the study report. All effects noted were fully reversible within 72 hours with only minor effect still being documented in one animal at 48 hours post treatment

No observations are noted as being made on days 4 and 7.

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: study author
Conclusions:
Molyvan 855 was found to be moderately irritating.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin Irritation:

Key study

In a GLP study similar to OECD 404, New Zealand White Rabbits exposed to Molyvan 855 slight erythema and eshcar formation was the primary effect observed in animals up until 76 hours post dosing. Slight edema formation was observed in two animals post dosing up to 28 hours post dosing (Food and Drug Research Laboratories, Inc, 1985).

Eye Irritation:

Key study

In a GLP study similar to OECD 405, using New Zealand White rabbits, all effects noted were fully reversible within 72 hours with only minor effect still being documented in one animal at 48 hours post treatment, Molyvan 885 was found to be moderately irritating (Food and Drug Research Laboratories, Inc, 1985).


Justification for selection of skin irritation / corrosion endpoint:
Well conducted study similar to OECD 404 under GLP conditions.

Justification for selection of eye irritation endpoint:
Well conducted study similar to OECD 405 under GLP conditions.

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: moderately irritating

Justification for classification or non-classification

Skin irritation:

In the key study conducted similar to OECD 404 under GLP conditions, slight erythema and eshcar formation was the primary effect observed in animals up until 76 hours post dosing; slight edema formation was observed in two animals post dosing up to 28 hours post dosing (Food and Drug Research Laboratories, Inc, 1985) therefore, according to Regulation EC No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Molyvan 855 is not classified for skin irritation/corrosion.

Eye irritation

In the key study conducted similar to OECD 405 under GLP conditions, all effects noted were fully reversible within 72 hours with only minor effects still being documented in one animal at 48 hours post treatment, (Food and Drug Research Laboratories, Inc, 1985).

Therefore, according to Regulation EC No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Molyvan 855 is not classified for eye irritation.