Naphthalenesulfonic acid, di-C9-rich C8-10-branched alkyl derivs., calcium salts

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was a well-conducted human repeat insult patch study.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Human repeated insult patch study with 104 volunteers

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

calcium bis(di C8-C10, branched, C9 rich alkylnaphthalenesulfonate)

IUPAC Name:

calcium bis(di C8-C10, branched, C9 rich alkylnaphthalenesulfonate)

Test material form:

liquid: viscous

Details on test material:

NASUL 729 is a formulation containing 50% Calcium bis( di c8-c10, branched, c9 rich, alkylnaphthalene sulphonate) and 50% petroleum Distillate.
Subjects received NA-SUL 729 as a 15.0% w/w liquid with Squibb Mineral Oil as the diluent.

Method

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

104 volunteers (light skinned) ages 18-70 years old

Route of administration:

dermal

Details on study design:

NA-SUL 729 (15.0% w/w in Squibb Mineral Oil) was occlusively applied to the skin of the infrascapular area of the back, between the shoulder
blades, using Finn Chambers (8 mm inner diameter aluminum chambers affixed to Scanpor Tape). The Induction Phase consisted of nine (9)
consecutive occlusive applications of the test material for a period of three weeks. The patches were removed approximately forty-eight (48) hours after each application. The subjects returned to the facility at forty-eight (48) hour intervals for evaluation of the treated sites,
and to have identical patches applied. Following the ninth evaluation, the subjects were released for a seventeen (17) day rest period prior to the Challenge Phase.
The Challenge Phase was initiated during the sixth week of the study, with identical patches applied to previously unexposed sites. Patches were
applied on Wednesday [February 15, 1995]. These patches were removed after forty-eight (48) hours. Skin reactions were graded in a manner
identical to that described above.

Results and discussion

Results of examinations:

see table

Any other information on results incl. tables

SUBJECTS' REACTIONS DURING THE CHALLENGE PHASE

 

Erythema grade	Number of reactions at the 48-hour observation (N=104)	Number of reactions at the 96-hour observation (N=104)
0	100	102
+0.5	4	1
+1.0	0	1
+2.0	0	0
+3.0	0	0

Applicant's summary and conclusion

Conclusions:

Under the conditions employed in this study, NA-SUL 729 (CRU #94777; 15.0% w/w in Squibb Mineral Oil) did not act as a skin sensitizer under
occluded (severe exposure) conditions in any of the 104 human volunteers.

Executive summary:

NA-SUL 729 (15.0% w/w in Squibb Mineral Oil) was occlusively applied to the skin of the infrascapular area of the back, between the shoulder blades, using Finn Chambers (8 mm inner diameter aluminum chambers affixed to Scanpor Tape). The Induction Phase consisted of nine (9) consecutive occlusive applications of the test material for a period of three weeks. The patches were removed approximately forty-eight (48) hours after each application. The subjects returned

to the facility at forty-eight (48) hour intervals for evaluation of the treated sites, and to have identical patches applied. Following the ninth evaluation, the subjects were released for a seventeen (17) day rest period prior to the Challenge Phase.

 

The Challenge Phase was initiated during the sixth week of the study, with identical patches applied to previously unexposed sites. Patches were applied on Wednesday [February 15, 1995]. These patches were removed after forty-eight (48) hours. Skill reactions were graded in a manner identical to that described above. At challenge, one subject (#031) out of 104 experienced a reaction of +1 <suggestive of contact sensitization) at the 96-hour observation. A rechallenge test was conducted with subject #031 in order to determine whether the reaction was due to allergic contact dermatitis. In addition to NA-SUL 729 (15.0% w/w in mineral oil), the subject was challenged with NA-SUL 729 (10.0% w/w in mineral oil), NASUL 729 (5.0% w/w in mineral oil), and the vehicle (100% Squibb Mineral Oil). Upon rechallenge" no reactions (i.e., grades of zero) indicative of contact sensitization were observed.

 

CONCLUSION:

Under the conditions employed in this study, NA-SUL 729 (CRU #94777; 15.0% w/w in Squibb Mineral Oil) did not act as a skin sensitizer under occluded (severe exposure) conditions in any of the 104 human volunteers.