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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
other information
Study period:
28 February 1977 to 8 April 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Cross-reference
Reason / purpose for cross-reference:
reference to same study
Remarks:
Skin irritation and Skin sensitization study results in one study report.
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
0.1 ml. of the test sample instilled into the right eye with no further treatment. as its own control. The untreated left eye of each animal served Both the treated and control eyes were examined every twenty-four hours for four days and then again on the seventh day. The scorings recorded were made according to the Draize scale for scoring ocular lesions.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
No information reported.
Vehicle:
other: Mineral oil
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration (if solution): 20 %
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
Draize scale for scoring ocular lesions.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritation observed.
Interpretation of results:
study cannot be used for classification
Conclusions:
The test substance in 20% mineral oil did not produce irritating effects.
Executive summary:

Three normal, healthy, albino rabbits were used in this experiment. The method of procedure is that suggested by Dr. Draize.

Each animal had 0.1 ml. of the test sample instilled into the right eye with no further treatment as its own control. The untreated left eye of each animal served Both the treated and control eyes were examined every twenty-four hours for four days and then again on the seventh day. The scorings recorded were made according to the Draize scale for scoring ocular lesions. Exposure to the test substance did not produce any irritation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Induction phase: The patch was occlusive and remained in situ for twenty-four hours.

Skin Scoring scale:
0 - No visible erythema.
1 - Erythema.
2 - Erythema plus swelling.
3 - Erythema, swelling, plus papules.
4 - Severe irritation consisting of erythema, swelling, papules, and necrosis and extension beyond the boundaries of contact.

If the reaction was not substantial, i.e., not in excess of a grade of 1, the test material was reapplied to the same site for twenty-four hours. This procedure was repeated on Wednesday and Thursday for a total of four consecutive exposures each week for three weeks. After the fourth patch was removed and read each Friday, the patch sites were rested on Saturday and Sunday. If any patch site developed a reaction of 2 or greater, the investigator could, at his discretion, continue subsequent applications on that same site or on a new site, and continue the same type of patch (occlusion) or change to semioccluded or open applications. In all, a total of twelve applications and readings were scheduled for the induction period.

Challenge Phase: On the 36th day of the study, after a rest period of slightly more than two weeks, the test material was applied on a new site as a challenge. At the end of twenty-four hours, the occluded patch was removed and the site was read for the immediate response. Followup readings were made twenty-four, forty-eight, and seventy-two hours later.
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
Historical skin sensitisation data already available to fulfill endpoint requirement.

Test material

Constituent 1
Chemical structure
Reference substance name:
Lanolin, hydroxylated
EC Number:
270-315-8
EC Name:
Lanolin, hydroxylated
Cas Number:
68424-66-8
IUPAC Name:
Lanolin, hydroxylated
Test material form:
solid

In vivo test system

Test animals

Species:
other: Human volunteers
Strain:
other: Human volunteers
Sex:
male/female
Details on test animals and environmental conditions:
Not specified

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
20%, 40%, 60%, 80%, and 100% concentration with a density of application of approximately 0.1 rnL of the test material per square centimeter.
Day(s)/duration:
24
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
Applied on day 36 to a virgin site
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
53
Positive control substance(s):
not specified

Results and discussion

Positive control results:
N/A

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
other: Application No. 1
Hours after challenge:
24
Group:
test chemical
Dose level:
20 - 100% concentration
No. with + reactions:
0
Total no. in group:
53
Clinical observations:
The test material, at concentrations ranging from 20% to 100%, did not elicit any visible evidence of irritation in any of the individuals under test.
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: Application Nos. 2 - 4
Hours after challenge:
24
Group:
test chemical
Dose level:
20 - 100% concentration
No. with + reactions:
0
Total no. in group:
53
Clinical observations:
The test material, tested at 100%, did not elicit any visible evidence of irritation in any of the individuals under test.
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: Application Nos. 5 - 12
Hours after challenge:
24
Group:
test chemical
Dose level:
100% concentration
No. with + reactions:
0
Total no. in group:
53
Clinical observations:
The test material, at conc. ranging from 20% to 100%, did not elicit any visible evidence of irritation in any of the individuals. On the basis of these results, it was decided that all subsequent applications were at 100% concentrations.
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: Application No. 13, Challenge
Hours after challenge:
24
Group:
test chemical
Dose level:
100% concentration
No. with + reactions:
0
Total no. in group:
53
Clinical observations:
The test material, tested at 100%, did not elicit any visible evidence of irritation in any of the individuals under test.
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No visible skin damage was observed in any of the individuals participating in this test. This evidence of apparent innocuousness enables the investigator to express an opinion that there is nothing in the results which could be construed to be a contraindication to the use of this material in a general human population.
Executive summary:

53 human volunteers were used in the skin sensitization study with the test material applied occlusively between 20 - 100% concentration. No visible skin damage was observed in any of the individuals participating in this test. This evidence of apparent innocuousness enables the investigator to express an opinion that there is nothing in the results which could be construed to be a contraindication to the use of this material in a general human population.