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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study was well conducted with no deficiences

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
A relevant study was available that fulfilled the requirement for the LLNA study.

Test material

Constituent 1
Reference substance name:
Hydrocarbons, C12-C16, n-alkanes, isoalkanes, alkenes
EC Number:
810-258-3
Molecular formula:
not applicable; UVCB
IUPAC Name:
Hydrocarbons, C12-C16, n-alkanes, isoalkanes, alkenes
Constituent 2
Reference substance name:
Alcohols, C2-33, manuf. of, by-products from overheads
IUPAC Name:
Alcohols, C2-33, manuf. of, by-products from overheads
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): HF-1000 solvent
- Substance type: Product
- Physical state: Clear, colourless, oily liquid1
- Analytical purity: 100%
- Lot/batch No.: 1881046
- Expiration date of the lot/batch: 03/29/18
- Storage condition of test material: ambient

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: HA (BR)
Sex:
male
Details on test animals and environmental conditions:
Species: Cavia porcellus (guinea pig)
Strain: HA (BR)
Source: Charles River Canada
Sex: Males
Body Weight Range: 342.8 g - 398.0 g
Number of Animals: Treatment group – 20
Negative Control group - 10
Positive Control group - 5
Acclimatization Period: 8 days
Age at Study Start: 4-5 weeks
Animal Identification: Colour coding, cage labels

Guinea pigs were housed in separate quarters in solid bottom cages, 5 per cage.
Individual animals were identified by colour coding; the animal number and group
number also appeared on the outside of each cage to preclude mix-up. The animal
room environment was controlled (targeted ranges: temperature 18ºC to 26ºC, relative
humidity 30-70% minimum 10 air changes per hour) and monitored. The photo-cycle
was 12 hours light and 12 hours dark. Upon arrival all animals were submitted to a
general physical examination and all were found healthy and were admitted. The
cage cleaning schedule, air filtration and recirculation, health checks and facility
maintenance were carried out in accordance with the applicable Nucro-Technics’
Standard Operating Procedures, and such activities were recorded in the animal room
records.
Animals were housed and maintained according to the AAALAC International Guide
for the Care and Use of Laboratory Animals, CCAC Guidelines for Care and Use of
Experimental Animals and Nucro-Technics’ Standard Operating Procedures.

Teklad Guinea Pig Diet and water were offered ad libitum throughout the
acclimatization and study periods.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: none
Concentration / amount:
induction- 100%
Challenge- 100%
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: none
Concentration / amount:
induction- 100%
Challenge- 100%
No. of animals per dose:
20- test substance group
10- control (naive)
5- positive control- 0.3% DNCB
Details on study design:
Three groups of Hartley guinea pigs were used. Twenty animals were in the test group, ten
animals in the solvent control group and five animals were in the positive control group.
The test item, HF-1000 Solvent, was applied “as is” to 2.5 x 2.5 cm gauze patches. The
gauze patches were then topically applied for a 6-hour exposure period to the shaved left
flanks of 20 guinea pigs on Days 0, 7 and 13. The applications on Days 0, 7 and 13
represented the induction phase of the study. 14 Days after the final induction application
(Day 27), a 2.5 x 2.5 cm gauze patch loaded with the test item, HF-1000 Solvent, was
applied to the shaved right flank of each animal in the Test Group for a 6-hour exposure
period. This application represented the challenge application.
A naïve control group, consisting of 10 animals was used. During the induction phase (Days
0, 7, and 13) the left flank of each control animal was shaved and a blank 2.5 x 2.5 cm gauze
patch was applied on each animal. On Day 27 (Challenge Phase), the test item, HF-1000
Solvent, was applied to the shaved right flank of each control animal for a 6-hour exposure
period.

A group of 5 positive control animals was subjected to identical procedures as outlined above
for the test group of animals (induction phase), with the exception that the positive control
item, 0.3% 1-chloro-2, 4-dinitrobenzene (DNCB), was substituted as a reference substance.
During the challenge phase, the positive control item (0.1% DNCB) was applied to the
shaved right flank of each positive control animal.

An evaluation of skin reaction was carried out and recorded at 24 hours and 48 hours after
completion of each application.
Challenge controls:
The animals in the positive control group were subjected to similar
procedures and evaluations on Days 0, 7 and 13 as described for the animals
in the test item-treated group with the exception that 0.3% w/v DNCB was
substituted as a reference substance.
Positive control substance(s):
yes
Remarks:
1-chloro-2,4-dinitrobenzene (DNCB)

Results and discussion

Positive control results:
100% (5/5) positive

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none remarkable
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none remarkable.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none remarkable
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none remarkable.
Reading:
1st reading
Hours after challenge:
24
Group:
other: naive
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none remarkable
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: naive. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none remarkable.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: naive
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none remarkable
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: naive. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none remarkable.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.3%
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
none remarkable
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.3%. No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: none remarkable.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.3%
No. with + reactions:
5
Total no. in group:
5
Clinical observations:
none remarkable
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.3%. No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: none remarkable.
Group:
negative control
Remarks on result:
not measured/tested

Any other information on results incl. tables

not applicable

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
Based on the results, HF-1000 Solvent was found to be non-sensitizing in a Buehler Skin
Sensitization Study in guinea pigs.
Executive summary:

A skin sensitization study of the test item, HF-1000 Solvent, in guinea pigs was carried out by Nucro-Technics according to Study Plan No. INT/296962. Three groups of Hartley guinea pigs were used. Twenty animals were in the test group, ten animals in the solvent control group and five animals were in the positive control group. The test item, HF-1000 Solvent, was applied “as is” to 2.5 x 2.5 cm gauze patches. The gauze patches were then topically applied for a 6-hour exposure period to the shaved left flanks of 20 guinea pigs on Days 0, 7 and 13. The applications on Days 0, 7 and 13 represented the induction phase of the study. 14 Days after the final induction application (Day 27), a 2.5 x 2.5 cm gauze patch loaded with the test item, HF-1000 Solvent, was applied to the shaved right flank of each animal in the Test Group for a 6-hour exposure period. This application represented the challenge application. A naïve control group, consisting of 10 animals was used. During the induction phase (Days 0, 7, and 13) the left flank of each control animal was shaved and a blank 2.5 x 2.5 cm gauze patch was applied on each animal. On Day 27 (Challenge Phase), the test item, HF-1000 Solvent, was applied to the shaved right flank of each control animal for a 6-hour exposure period. A group of 5 positive control animals was subjected to identical procedures as outlined above for the test group of animals (induction phase), with the exception that the positive control item, 0.3% 1-chloro-2, 4-dinitrobenzene (DNCB), was substituted as a reference substance. During the challenge phase, the positive control item (0.1% DNCB) was applied to the shaved right flank of each positive control animal. An evaluation of skin reaction was carried out and recorded at 24 hours and 48 hours after completion of each application. None of the guinea pigs administered the test item had any signs of local skin irritation after the induction applications or after the challenge period. All 5 of the positive control animals showed a positive response. Based on these findings, the test item, HF-1000 Solvent, was found to be non-sensitizing in a Buehler Skin Sensitization Study in guinea pigs.

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