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Diss Factsheets

Administrative data

Description of key information

In the Buehler assay the substance was shown to be a weak skin sensitiser, while a human patch test showed no sensitization in human volunteers.
The key study is the human patch test as described in chapter 10. The results of the human patch test in 104 volunteers showed that the substance is not sensitizing

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 7 - March 17, 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study followed EPA guidelines and was carried out in compliance with Product Safety Labs Standard Operating Procedures. The number of animals in the test group was 10 and therefore the conclusions of the study are considered less reliable.
Qualifier:
according to guideline
Guideline:
EPA OPP 81-6 (Skin Sensitisation)
Deviations:
no
Principles of method if other than guideline:
40 CFR Part 158, subdivision F: Pesticide Assessment Guidelines
Hazard Evaluation-Human and Domestic Animals
NTIS:PB86-10B95B: Section 81-6; pp. 59-62
GLP compliance:
no
Remarks:
This study was carried out in compliance with Product Safety Labs Standard Operating Procedures. There were no deviations that impacted the integrity or validity of the study.
Type of study:
Buehler test
Justification for non-LLNA method:
Adequate existing data that allow a conclusion on the sensitizing potential of the substance were available
Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:

Acclimation period - 7 days.
Allocation:
Test Group 10 Guinea Pigs
Positive Control Group 10 Guinea Pigs
Naive Control Group 5 Guinea Pigs
Replacement Naives 5 Guinea Pigs
Caging - Gang-caged in suspended stainless steel cages with mesh floors.
Room temperature - 64-72cF
Food - Purina Guinea Pig Pellets ad-libitum.
Water - tap water supplied by automatic water system.
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100% (undiluted) - 0.4 ml
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100% (undiluted) - 0.4 ml
No. of animals per dose:
see table
Details on study design:
see table
Challenge controls:
see table
Positive control substance(s):
yes
Remarks:
0.08% Dinitrochlorobenzene (DNCB) in 80% ethyl alcohol
Positive control results:
All animals had a faint to moderate erythematous response 24 and 48 hours post-challenge. Nine sites were calculated to be positive. Most
sites also exhibited edema. By 72 hours the incidence of positive reactions decreased to 4. The level of severity remained faint to moderate.
Reading:
other: 3thd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0.4 ml
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
0.0 severity
Remarks on result:
other: Reading: other: 3thd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.4 ml. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 0.0 severity.
Reading:
other: 3thd reading
Hours after challenge:
72
Group:
positive control
Dose level:
0.4 ml
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
1.25 severity reading
Remarks on result:
other: Reading: other: 3thd reading. . Hours after challenge: 72.0. Group: positive control. Dose level: 0.4 ml. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: 1.25 severity reading.
Reading:
other: 3thd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0.4 ml
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
0.0 severity
Remarks on result:
other: Reading: other: 3thd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0.4 ml. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: 0.0 severity.
Reading:
rechallenge
Hours after challenge:
72
Group:
test chemical
Dose level:
0.4 ml
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
0.5 severity
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 72.0. Group: test group. Dose level: 0.4 ml. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: 0.5 severity.
Reading:
rechallenge
Hours after challenge:
72
Group:
positive control
Dose level:
0.4 ml
No. with + reactions:
8
Total no. in group:
10
Clinical observations:
1.13 severity
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 72.0. Group: positive control. Dose level: 0.4 ml. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: 1.13 severity.
Reading:
rechallenge
Hours after challenge:
72
Group:
negative control
Dose level:
0.4 ml
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
0.0 severity
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 72.0. Group: negative control. Dose level: 0.4 ml. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: 0.0 severity.
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
Based on these findings and an the evaluation of the test system, NA-SUL 729, Lot #3158 is considered to be a minimal contact sensitizer
when applied as received, undiluted, once a week for 3 weeks.
Executive summary:

A guinea pig sensitization test following the Buehler procedure (EPA Guideline 81-6) was conducted with NASUL 729.After establishing the highest non-irritating dose concentration to be100%,a 3week induction period was initiated during which10young adult male guinea pigs were treated with the test substanceand 10were treated with 0.08%Dinitrochlorobenzene (DNCB) in 80%ethyl alcohol (positive controls). During the induction period the animals were dosed once week until a total of three dose applications was achieved. Fourteen days after the third application a challenge dose was applied to anaive site on each guinea pigandapproximately 24, 48 and72hours later the animals were scored for a sensitization response (erythema and edema). A naive control group of five animals was maintained under the same environmental conditions and treated with the test substance at challenge only. Because of the positive response observed in the naive animals after challenge, the animals from all groups were allowed to rest for 7 days and were then re-challenged. A second group of naive animals was also dosed at this time.

 

All guinea pigs appeared active and healthy throughout the test period. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behavior. All animals gained weight.

 

INDUCTION PHASE:

Test Animals:Very faint erythema and edema were observed at 1 test site 24 hours after the first inductions. Virtually all animals exhibited erythema which varied from very faint to moderate after the second and third inductions. Edema was also noted at almost all sites after the second and third induction.

Positive Control Animals(0.08%DNCB in80%Ethyl Alcohol):sixanimals exhibited erythema 24 hours after the first induction and all had faint to moderate-severe erythema with faint edema after the

second and third inductions.

 

CHALLENGE PHASE:

FIRST CHALLENGE:

Test Animals:Five test sites exhibited a positive response 24 and 48 hours after challenge. At one site moderate erythema with edema was noted. Most other sites exhibited only faint erythema. By 72 hours all signs of irritation disappeared.

Naive Control Animals:Onenaive site exhibited very faint erythema at 24 and 48 hours postchallenge. By 72 hours erythema had cleared from the site. No irritation was noted atanyother naive site.

Positive Control Animals(0.08% DNCB in80%Ethyl Alcohol):~lanimals had a faint to moderate erythematous response24and48hours post-challenge. Nine sites were calculated to be positive. Most

sites also exhibited edema. By72hours the incidence of positive reactions decreased to4. Thelevel of severityremainedfaint to moderate.

 

RE-CHALLENGE:

Test Animals:Seven test sites hadapositive response at 24 hours after re-challenge. The severity of erythema was very faint non-confluent to faint confluent. By 72 hours very faint erythema remained at most of these sites.

Naive Control Animals:No irritation was noted atanyof the naive control sites after rechallenge.

Positive Control Animals(0.08%DNCE in80%Ethyl Alcohol):Nine positive responses were observed at 24 and 48 hours after the second challenge. Erythema varied in severity from very faint to

strong. By 72 hours eight sites were positive.

 

Based on these findings, NA-SUL 729,#3158 is considered to be a minimal contact sensitizer

when applied as received, undiluted, once a weekfor3 weeks. The positive response to 0.08% DCNB in 80% Ethyl Alcohol validates the test system used in this study.

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

In a Buehler test performed the substance was shown to be a skin sensitiser when applied to guinea pig skin. A study with 104 human volunteers only showed a very low number of sensitisation findings (n=4). Based on the human findings, the substance is not classified for skin sensitization.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the human patch test the substance is not classified as sensitizing to the skin. Data for respiratory sensitisation are lacking.