Registration Dossier

Administrative data

Description of key information

The key skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, concluded the test material to be not irritating to skin (IFREB, 1982).

The key eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, concluded the test material to be corrosive and to cause irreversible damage to eyes (IFREB, 1982).

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:
supporting study
Study period:
07.09.1981 to 11.09.1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24 hour exposure
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Buckshire Corporation, Perkasie, Pennsylvania.
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: Individually in suspended steel wire mesh cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 12 days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±2
- Humidity (%): 50± 5
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 07.09.1981 to 11.09.1981
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
24 hour(s)
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap if used: No wrap used. The treated patch of gauze was secured on two opposing edges with narrow strips of surgical tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done


SCORING SYSTEM: Draize
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
1.94
Max. score:
8
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 96 hours
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 96 hours
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 96 hours
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 96 hours
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 96 hours
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 96 hours
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 96 hours
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
All six animals developed well-defined erythema (grade 2) 24 or 48 hours after application, which remained in all animals to 96 hours. One animal had persistent erythema (grade 1) to 168 hours. There was no oedema.
Other effects:
None reported.

No irritation was observed at the untreated sites of all animals. Significant irritation was observed in the positive
control animals which had a PII score of 5.22

Interpretation of results:
Category 3 (mild irritant) based on GHS criteria
Remarks:
Not classified according to Regulation (EC) No. 1272/2008.
Conclusions:
In a skin irritation study (reliability score 2) conducted using a protocol similar to OECD 404, but not to GLP, Prylog was mildly irritating to the skin of rabbits following 24 hours exposure. Based on the available information, the substance does not meet the current EU criteria for classification as a skin irritant.
Executive summary:

In a skin irritation study (reliability score 2) conducted using a protocol similar to OECD 404, but not to GLP, Prylog was mildly irritating to the skin of rabbits following 24 hours exposure.

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:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to
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
- Age at study initiation: no data available
- Weight at study initiation: ca. 2.5 kg
- Housing: individual polystyrene cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 30-70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: the other eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
4 hours
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
6 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: not stated in report

SCORING SYSTEM:

TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.5
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2.5
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.5
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.66
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.83
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.6
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.5
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.5
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.33
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3.67
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3.33
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
All animals demonstrated effects of irritancy, the study report concluding the test substance to be a severe irritant/corrosive in 4/6 rabbits.
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The test material was found corrosive to rabbit eye in a study conducted according to OECD TG 405 and in compliance with GLP.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The key study for skin irritation was conducted according to a test protocol that is comparable to OECD Test Guideline 404 and in compliance with GLP. The test material was found to be mildly irritating to the skin of rabbits. However, based on the available information, the substance does not meet the current EU criteria for classification and is therefore not classified as a skin irritant (IFREB, 1982).

A supporting skin irritation study which was conducted according to a test protocol that is comparable to OECD Test Guideline 404 and in compliance with GLP reported that the test substance was not irritating to the skin of rabbits (Allied Corporation, 1982).

A supporting study conducted using a protocol similar to OECD Test Guideline 404, but which pre-dated GLP, reported no irritation to skin after a 24 hours exposure to undiluted test material (Dow Corning Corporation, 1976).

In a skin irritant toxicity study that is comparable to OECD Test Guideline 404, however, not in compliance with GLP, reported that the test substance was not irritating to the skin of rabbits following 24 hours exposure (Dow Corning Corporation, 1976).

A reliability 4 summary report was also available, which reports the test material to receive the score of three in a 10-grade rating system in rabbits (Mellon Institute of Research, 1962).

The key study for eye irritation was conducted according to OECD Test Guideline 405 and in compliance with GLP. The study found the test material to be a severe irritant to rabbit eye, with corneal, iridial and conjunctival effects persisting until experimental day 21 (IFREB, 1982).

A supporting study for eye irritation, which was conducted according to a test protocol that is comparable to OECD Test Guideline 405, but was not in compliance with GLP. In unwashed eyes treated with undiluted test substance, blinking and tearing were observed in all eyes within minutes after instillation. Corneal opacities, covering a minimal area of the cornea persisted for 21 days in 2 of the 6 animals which had developed pannus of the cornea. In the washed eyes, treated with undiluted test material and washed 20 seconds later, minimal signs of irritation were reported. No irritation was evident in the washed or unwashed eyes of rabbits exposed to 5% of the test material in water. Based on the available information the test material was deemed irritating to the eye (Allied Corporation, 1982).

A supporting study conducted according to a test protocol that is comparable to OECD Test Guideline 405, which pre-dated GLP, reports mild irritation in animals in which the treated eyes remained unwashed. No effects are reported to persist beyond 48 hours, and the study concludes the test material to be mildly irritating to the eyes of rabbits (Dow Corning Corporation, 1976).

A reliability 4 summary report was also available, which reports the test material to receive the score of two in a 10-grade rating system in rabbits (Mellon Institute of Research, 1962).

A supporting eye irritation study which was not conducted according to any guideline and not in compliance with GLP, reports that slight pain and very slight conjunctival redness was observed in both eyes immediately following exposure. Conjunctival redness persisted for 24 hours whereas no irritation was observed following 48 hours (Dow Corning Corporation, 1981).

In a reliability 4 eye irritation study which was pre-guideline and pre-GLP, the test substances caused moderate pain with essentially no irritation to the washed or unwashed eyes in rabbits (Dow Corning, 1958).

In another reliability 4 eye irritation study which was not conducted according to any guideline, it was observed that the test substance was found to be mildly irritating in vitro (Gautheron et al., 1994).

In a reliability 4 study which was conducted in a similar way to OECD Test Guideline 405, the substance was not irritating to minimally irritating in rabbits (Gautheron et al., 1994).

Justification for classification or non-classification

Based on the available in vivo data, the substance does not require classification for skin irritation according to Regulation (EC) No. 1272/2008.

Based on the key study for eye irritation, classification for irreversible effects on the eye is appropriate, Eye Dam. 1; H318: Irreversible effects on the eye", according to the criteria of Regulation (EC) No 1272/2008.