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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across source
Positive control results:
100% (5/5) positive
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

not applicable

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, the source substance, 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, the source substance, was found to be non-sensitizing in a Buehler Skin Sensitization Study in guinea pigs.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A skin sensitization study of the test item, HF-1000 Solvent (the source substance), 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 (the source substance), was found to be non-sensitizing in a Buehler Skin Sensitization Study in guinea pigs


Migrated from Short description of key information:
The test item, HF-1000 Solvent, the source substance, was found to be non-sensitizing in a Buehler Skin Sensitization Study in guinea pigs

Justification for classification or non-classification