Registration Dossier

Administrative data

Description of key information

Based on pre-GLP in-vivo studies with a mixture of C12 -15 -alkyl lactate esters.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The test is non-GLP but the parameters documented partially comply with a specific testing guideline.
Justification for type of information:
See section 13 for justification of read across.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Observations only after 24 and 72 h.
Principles of method if other than guideline:
The irritation index is based on the Draize method in this study. Presently, this method is no longer used for determination of the degree of irritation.
GLP compliance:
no
Species:
rabbit
Strain:
other: normal albino
Type of coverage:
occlusive
Preparation of test site:
other: Clipped with minor abrasions
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
24
Observation period:
At the end of the 24-hour period and 48 hours later. Scoring of irritation according to the method of Draize.
Number of animals:
3
Details on study design:
0.5 ml test substance applied on the scarified and 0.5 ml on non-scarified area, which were covered with Webril patches. Animals were immobilized in racks for the 24-hour period.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Intact skin: 0; abraded skin: 1
Irritation parameter:
erythema score
Basis:
other: total
Time point:
other: 72 h
Score:
3
Max. score:
4
Reversibility:
other: Not reversible at 72h for abraded skin
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Basis:
other: total score
Time point:
other: 72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Other effects:
Not specified.
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Scoring according to Draize
Conclusions:
Since the test material produced a primary irritation index of 0.5 it can be considered as a very mildly primary irritant and not sufficient for classification.
Executive summary:

CERAPHYL® 41 was moderately irritating to rabbit skin. Three albino rabbits each received a single dermal application of CERAPHYL® 41 (0.5 ml) on one intact and abraded site per rabbit for 24 hours under occlusion. Dermal reactions were scored at 24 and 72 hours after unwrapping. Moderate erythema was observed at 24 hours on intact skin and at 24 and 72 hours on abraded skin. No edema was observed at any time. The primary irritation index was 0.5.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Remarks:
The in-vivo study is performed before in-vitro testing was preferably applied.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The test is non-GLP but the parameters documented partially comply with a specific testing guideline.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
7 days
Observation period (in vivo):
Every 24 hours for four days and on the seventh day.
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: all
Score:
0
Max. score:
80
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: all
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: day 7
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: Score of 3 at 24 h
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #3
Time point:
other: 72h, 96h and day 7
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: Score of 2 at 24 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 96 and day 7
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Score of 3 at 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: all
Score:
0
Max. score:
80
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: all
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: Score of 2 at 24 - 72 h
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: Score of 1 at 24 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 96 h - day 7
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Score of 2 at 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: all
Score:
0
Max. score:
80
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: all
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
7 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: Score of 3 at 24 h
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #1
Time point:
other: 48h - day 7
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: Score of 1 at 24 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 72h - day 7
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Score of 2 at 24 h
Other effects:
Not recorded.
Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Installation of 0.1 ml of the test material into the right eye of three rabbits produced a moderate irritation involving only the conjunctivae. On the seventh day of observation these eyes were normal showing full reversibility.
Executive summary:

C12 -15 alkyl lactates were mildly irritating to the eyes of rabbits. Three albino rabbits received a single application of CERAPHYL® 41 (0.1 ml) into the conjunctival sac of one eye. The contralateral eye, remaining untreated, served as a control. The eyes were examined and scored for effects on the cornea, iris and conjunctiva on Days 1, 2, 3, 4 and 7 after treatment. No corneal opacity or iritis was observed. Conjunctival irritation, noted in all the eyes, cleared by Day 7.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Lactate esters are generally significant eye irritants but not or only slightly irritant to skin. The irritation of the eyes is probably due to hydrolysis producing free lactic acid.

Justification for classification or non-classification

The studies on skin irritation show Draize primary irritation indeces of 0.3 and 0.5. According to Draize, values less than 2 should be considered as non- to mildly irritating. Hence, no classification for skin irritation is relevant.

The studies on eye irritation indicate that the product was mildly irritating to the eyes of rabbits involving only the conjunctivae. Further, the effect was fully reversible. The substance should be classified as Irritating to eyes (Category 2) because it produced positive but reversible responses in at least 2 of 3 tested animals, namely: conjunctival redness ≥ 2 and conjunctival oedema (chemosis) ≥ 2. Reversibility within 7 days allows for GHS classification of cat. 2B.