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Diss Factsheets

Administrative data

Description of key information

There is one eye irritation study (Latven, 1976) and one skin irritation study (Latven, 1976).

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
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
other:
Version / remarks:
before the publication of the guideline
Principles of method if other than guideline:
One half ml of the sample was applied to one contact and one abraded skin site under standard gauze patches on each of three albino rabbits. The entire hair clipped truck of each animal was then covered with an impervious sleeve for a period of 24 hours.
GLP compliance:
no
Species:
rabbit
Strain:
other: albino
Type of coverage:
occlusive
Preparation of test site:
other: applied on one intact and one abraded skin on each of three rabbits
Amount / concentration applied:
one half mL
Duration of treatment / exposure:
24 hours
Observation period:
48 hours
Number of animals:
3 rabbits
Details on study design:
One half ml of the sample was applied to one contact and one abraded skin site under standard gauze patches on each of three albino rabbits. The entire hair clipped truck of each animal was then covered with an impervious sleeve for a period of 24 hours.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 15 minutes
Score:
4
Reversibility:
not reversible
Remarks on result:
other: The skin turned black within 15 minutes.24 hours after initial contact all sites consisted of large, round, black necrotic lesions.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 15 minutes
Score:
4
Reversibility:
not reversible
Remarks on result:
other: The skin turned black within 15 minutes.24 hours after initial contact all sites consisted of large, round, black necrotic lesions.
Irritation parameter:
edema score
Time point:
other: 15 minutes
Score:
4
Reversibility:
not reversible
Remarks on result:
other: The skin turned black within 15 minutes. 24 hours after initial contact all sites consisted of large, round, black necrotic lesions.
Interpretation of results:
Category 1A (corrosive) based on GHS criteria
Executive summary:

One half of the sample was applied to one intact and one abraded skin site under standard gauze patches on each of three albino rabbits. The entire hair-clipped trunk of each animal was then covered with impervious sleeve fora period of 24 hours. The sample spread well beyond the intended sites of contact and caused pain in every instance. The skin turned black within 15 minutes.Twenty-four hours after initial contact all trzated sites consisted of large (5cm) round, black, necrotic lesions. These became dry, hard, and concave within 48 hours. Subsequently they began to crack and peel, exposing raw tissues.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
before 1980, comparable to OECD 405
GLP compliance:
not specified
Species:
rabbit
Strain:
other: albino
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
one tenth ML
Duration of treatment / exposure:
1 minutes
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
One tenth animal was placed in the conjunctival sas of both eyes of three albino rabbits. One eye of each animal was washed with flowing water initiated fifteen seconds after instillation and continued for a period of one minute; the contraleral eye remained unwashed. The irritant reactions were scored periodically for seven days.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 10 min/1h/2h/4h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: not reversible within 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 10 mn/1hr/2hr/4hr
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks:
after 7 days
Remarks on result:
other: not reversible within 7 days
Irritation parameter:
conjunctivae score
Remarks:
chemosis
Basis:
other: mean
Remarks:
3 rabbits
Time point:
other: 10 mn/1hr/2hr/4hr
Score:
1
Max. score:
1
Reversibility:
not reversible
Remarks:
after 7 days
Remarks on result:
other: not reversible within 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: not reversible within 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: not reversible within 7 days
Irritation parameter:
conjunctivae score
Remarks:
chemosis
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not reversible
Remarks on result:
other: not reversible within 7 days
Irritant / corrosive response data:
Reactions in washed and unwashed eyes were identical. The cornea began to opacify immediately and opacification was virtually complete within 10 minutes (the iris and ppil were not discernible. Severe conjuntival inflammation also developed promptly. In addition, tissue necrosis appeared within minutes in portions of the conjunctivae and along the borders of the eyelids; the latter solidified within a day or two. The reaction persisted through the seventh day without change and appeared to be irreversible.
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Executive summary:

One tenth animal was placed in the conjunctival sas of both eyes of three albino rabbits. One eye of each animal was washed with flowing water initiated fifteen seconds after instillation and continued for a period of one minute; the contraleral eye remained unwashed. The irritant reactions were scored periodically for seven days. Reactions in washed and unwashed eyes were identical. The cornea began to opacify immediately and opacification was virtually complete within 10 minutes (the iris and pupil were not discernible. Severe conjunctival inflammation also developped promptly. In addition, tissue necrosis appeared within minutes in portions of the conjunctivae and along the borders of the eyelids; the latter solidified within a day or two. The reaction persisted through the seventh day without change and appeared to be irreversible.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Effects on skin irritation/corrosion:highly corrosive

Effects on eye irritation:corrosive

Justification for classification or non-classification

Proposed classification according to Regulation EC 1272/2008

Skin:       corrosive cat 1A

Eye: irreversible changes; cat 1