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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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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
Study period:
15th March 2017 to 14th April 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Read across from very similar calcium benzenesulfonic acid that was not overbased; further justification is provided in category document
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
A Buehler test was used for R&D purposes and worldwide acceptance, so an LLNA should not ethically be completed based on animal welfare reasons
Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
A toltl number of 32 animals were utilised for the study. Twenty test animals, ten negative control animals, and two pilot animals were used. Prior to use, all animals were acclimated for at least five days. Animals were individually housed in wire mesh suspension cages. The animals were maintained on a 12-hour cycle light controlled room, at a temperature of 64° - 79°F and a relative humidity of 30-70%. The animals were maintained according to the recommendations contained in t Pig Chow and tap water ad libitum during both acclimation and test periods. There were no contaminants in either the feed or the water that would be expected to affect the outcome of this study
Route:
epicutaneous, semiocclusive
Vehicle:
other: Mineral Oil
Concentration / amount:
0.4ml of 25% concentration of test substance
Day(s)/duration:
6 hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
other: Mineral Oil
Concentration / amount:
0.4ml of 10% concentration of test substance
Day(s)/duration:
6 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20 animmals used for both induction and challenge test.
Details on study design:
A pilot study was conducted using 2 animals to determine the concentration that produced mild dermal irritation at the application site which is then used for the inductions dose and the highest non irritating concentration of the test substance is then used as the challenge dose. The application site is prepared by removing hair from the back and sides of the trunk and four sites are selected for the irritation screening, 0.4ml of 5%, 10%, 25% and 50% of the test substance were applied to the test site and secured with micropore tape and further secured with kendal adhesive tape then left for 6 hrs after which the tape was removed and the irritation scores are taken a day after.

Similarly, application sites were prepared on test animals by shaving off hair and test substance is applied and secured with tape for 6hours after which tape is taken off and excess material wiped off. The test substance was administered to 20 young adults’ male Guinea pigs by dermal application at a dose volume of 0.4ml per application site for the Inductions and challenge. The does was based upon the appropriate amount of material sufficient to saturate the cotton pad in the Hilltop Chamber and allow for good skin contact of the test substance. Animals are scored for Irritation (erythema) at 24 and 48hours after completion of exposure. All animal body weight are taken before and after the study. In the challenge study, 6 negative control animals remained untreated through the induction phase and received primary challenge dose at 10% concentration of test substance. Four remaining guinea pigs were designated for a re-challenge if necessary.

All induction scores are recorded final challenge scores are reported after 24 and 48hrs.
Challenge controls:
6 negative control animals remained untreated through the induction phase and received primary challenge dose at 10% concentration of test substance. Four remaining guinea pigs were designated for a re-challenge if necessary.
Positive control substance(s):
yes
Remarks:
1-chloro-2,4-dintriobenzene: 0.3% in 80% ethanol for induction and 0.1% in acetone for challenge completed 18 days before this study was initiated
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10% concentration - Challenge phase
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: 2 of 20 animals gave positive indication of skin sensitization
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% Concentration - Challenge phase
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10% Concentration - Negative control
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10% Concentration
No. with + reactions:
0
Total no. in group:
6
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1% in acetone
No. with + reactions:
10
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1% in acetone
No. with + reactions:
10
Total no. in group:
10
Interpretation of results:
GHS criteria not met
Conclusions:
Following primary challenge of test substance at 10% concentration, the incidence of grade 1 response or greater in the test group (2 of 20) was compared to that of the naive control group (0 of 6). The incidence and severity of these responses were not significantly greater than those produced by the naive control group indicating that sensitization had not been induced. Based on GHS guidelines < 15% of animals were sensitized to the material therefore, the Test substance is not classified for skin sensitization.
Executive summary:

The Test substance was tested for dermal sensitization potential using a 25% induction concentration. The Test substance was evaluated for sensitization potential by applying 0.4 ml at a 25% concentration directly into Hilltop Chambers® and applying them to the clipped left shoulder of twenty albino guinea pigs in the following manner: The animals were held gently, and the chambers were applied as quickly as possible to the clipped left shoulder. The chambers were secured with Micropore tape and further secured with Kendall adhesive tape. Approximately six hours later, the tape and chambers were removed. Two additional induction doses were conducted following the same procedure, at weekly intervals. Two weeks after the final application the animals received a topical primary challenge dose (6hour contact) of test substance at 10% concentration, on a naive site located on the

right shoulder. Animals were scored for irritation at 24 and 48 hours after initiation of the primary challenge application. Ten guinea pigs served as a naive control group, and remained untreated through the induction phase. Six naive control animals received only the primary challenge dose, at a 10% concentration. The four remaining guinea pigs were designated for a re-challenge, if necessary.

Following primary challenge of test substance, at 10% concentration, the incidence of grade 1 response or greater in the test group (2 of 20) was compared to that of the naive control

group (0 of 6). The incidence and severity of these responses were not significantly greater than those produced by the naive control group indicating that sensitization had not been induced.

Based on GHS guidelines < 15% of animals were sensitized to the material, therefore, the Test substance is not classified for skin sensitization.

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

The read-across substance has been determined not to be sensitisers in guinea pig patch tests.

The test material and read-across substances have been determined to be non-sensitisers in human patch tests.

 

The read-across substance was Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts. This substance is very similar to the test substance except that it is not overbased. Further justification is provided in category document.

Low background incidences of sensitisation were observed among human volunteers, however, at levels that are considered to be not statistically significant. This lack of sensitisation in humans is further supported by human observations after exposure to the substance to be registered. Human sensitisation studies have been reported under ‘Exposure related observations in humans’.

.

Based on the weight of evidence provided, the test material is considered to be not sensitising.


Migrated from Short description of key information:
The read-across substance has been determined not to be a sensitiser in guinea pig patch tests.
The test material and read-across substances have been determined to be non-sensitisers in human patch tests.

Justification for selection of skin sensitisation endpoint:
The skin sensitisation endpoint has been addressed using both human and guinea pig read across studies and human studies on the test substance.
Human data presented under the endpoint “Sensitisation data (humans)” is also a key part of the weight of evidence for this endpoint. Two repeat insult patch tests using the substance to be registered and a further two studies performed on the read-across substances sodium 4-icosylbenzenesulfonate and sodium salt of sulfonated C15-C18 n-alpha-olefin, have also been provided to support the sensitisation dataset.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Migrated from Short description of key information:
Respiratory sensitisation has not been assessed.

Justification for classification or non-classification

Given that classification and labelling of chemicals is, by definition, a mechanism for the communication of hazard to humans, it is considered justifiable to assume a greater weight of relevance to data collected from human exposure compared to the data collected from exposure to guinea pigs. It is, therefore, considered justifiable to classify the substance according to the data available from human exposure.

Based on data available from human exposure, the substance is considered to be not sensitising in accordance with Regulation (EC) No. 1272/2008.