Registration Dossier

Administrative data

Description of key information

Skin corrosion/irritation in vivo: The registered substance was found to be non-corrosive and non-irritant to skin (OECD 404).

 

Eye irritation in vivo: The registered substance was found to cause serious eye damage (OECD 405).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin corrosion: 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 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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
Four hours
Observation period:
Four days
Number of animals:
Three
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 9 d
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 9 d
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.38
Max. score:
4
Reversibility:
fully reversible within: 9 d
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 9 d
Interpretation of results:
GHS criteria not met
Conclusions:
The substance was found to be non-irritating to rabbit skin.
Executive summary:

A study was performed to assess the skin irritation potential of Lakeland ACP 70 to the rabbit. The method followed was that described in OECD Guideline for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion". Adopted: 12 May 1981. Three rabbits were each administered a single dermal dose of 0.5 ml of the test substance and observed for four days, Well-defined dermal reactions were observed following a single semi-occlusive application of Lakeland ACP 70 to intact rabbit skin for four hours. The skins were normal by Day 9.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

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:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Single application (eye not subsequently irrigated)
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
Two
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 21 d
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 4 d
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 21 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 21 d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 21 d
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Ocular reactions persisted in one out of two animals at the end of the 21 day observation period.
Executive summary:

A study was performed to assess the eye irritation potential of Lakeland ACP 70 to the rabbit. The method followed was that described in OECD Guideline for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion". Adopted: 24 February 1987. Two rabbits were each administered a single ocular dose of 0.1 mI of the test substance and observed for 21 days after instillation. A single instillation of Lakeland ACP 70 into the eye of the rabbit elicited corneal opacification, transient iridial inflammation and considerable conjunctival irritation. These reactions resolved 21 days after instillation in one animal but persisted in the remaining animal.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Skin corrosion/irritation in vivo: The registered substance gave mean 24/48/72 h scores that were substantially below those triggering classification for skin irritation, evidence of skin corrosion was not reported, and all effects fully reversed within a 9-day observation period. The substance is therefore considered to be non-corrosive and non-irritant to skin under the terms ofRegulation 1272/2008 (8thATP).

 

Eye irritation in vivo: Mean 24/48/72 h scores for corneal opacity were reported as3 in two animals and corneal opacity/conjunctival redness were not reversed during the 21-day observation period in one animal. Classification as H318: Eye Dam 1 is therefore appropriate under the terms of Regulation 1272/2008 (8thATP).