[No public or meaningful name is available]

Endpoint summary

Description of key information

The studies performed on analogues (hydrolysed proteins obtained from different animal and vegetable sources) were prepared mostly for the safety assessment for cosmetic ingredients and didn't show the irritating potential either in skin nor on mucous membranes.

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Duration of treatment / exposure:

Treatment duration was 4 hours.

Observation period:

The skin reaction was assessed at approximately 1, 24, 48 and 72 hours after exposure

Number of animals:

3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Other effects:

no other effects

No abnormalities were detected in the skin of any animal in any of the observation times and hence the 72 hours was considered the end of the observation period in all animals.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the study and referring to the classification criteria (Commission Directive 2001/59/EC of 6 August 2001), the product is considered as "NO IRRITANT" on the skin of rabbits, it is not necessary to assign risk notation.

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

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Principles of method if other than guideline:

Draize method involve the instillation of 0,1 ml of a test liquid into the lower conjunctival cul-de-sac. Observations of various criteria (i.e., corneal opacity and area of corneal involvement, conjunctival hyperemia, chemosis, ocular discharges, and iris abnormalities) are taken at pre-defined intervals: 1, 24, 48, and 72 hours, and 1 week, after administration. Eyes were scored by Draize classification (max, 110) at 1, 2, 3, 4, and 7 days or until negative.

GLP compliance:

not specified

Remarks:

tests were performed in 1973

Specific details on test material used for the study:

50% solution tested

Species:

rabbit

Strain:

other: albino white

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

50% solution.

Observation period (in vivo):

7 days or until negative

Number of animals or in vitro replicates:

6

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

50% solution

Time point:

24 h

Score:

1

Max. score:

110

Reversibility:

fully reversible

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

50% solution

Time point:

48 h

Score:

0

Max. score:

110

Reversibility:

fully reversible

Irritant / corrosive response data:

Hydrolyzed Collagen was concluded to be minimally irritating

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not irritating to eyes

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available