Tetrabutylammonium bromide

Endpoint summary

Description of key information

Data available for the structurally and functionally similar read across chemicals to determine the skin sensitization potential of the test chemical. Based on the summarized,it can be concluded that the testchemical is unable to cause skin sensitization and considered as not sensitizing. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

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:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: weight of evidence approach based on similar chemicals

Justification for type of information:

Weight of evidence approach based on similar chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: Weight of evidence based on similar chemicals

Principles of method if other than guideline:

The weight of evidence report has been prepared based on the read across substances identified based on structural and functional similarity to assess the dermal sensitization potential of N,N,N-tributylbutan-1-aminium bromide (CAS No: 1643-19-2).

GLP compliance:

not specified

Type of study:

Buehler test

Species:

guinea pig

Strain:

other: 1.Pirbright albino 2.Pirbright white 3.not specified

Sex:

female

Details on test animals and environmental conditions:

No data available

Route:

other: 1.epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

4%

Day(s)/duration:

6 hours

Adequacy of induction:

not specified

Route:

other: 3.epicutaneous, occlusive

Vehicle:

not specified

Adequacy of induction:

not specified

No.:

#1

Route:

other: 1. epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

1%

Day(s)/duration:

6 hours

Adequacy of challenge:

not specified

No.:

#1

Route:

other: 2.epicutaneous, occlusive

Vehicle:

other: not specified

Adequacy of challenge:

not specified

No. of animals per dose:

1.Total :46
Preliminary study: 6 animals
Main study
Treated group:30
Control group:10

2.not specified

Details on study design:

1. Details on study design
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:3
- Exposure period: 6hr
- Test groups:30
- Control group:10
- Site: 2 x 2 cm cellulose patch to the clipped skin of the left flank.
- Frequency of applications: on day 1,8 and 15
- Duration: 15 days
- Concentrations: 4%

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: on day 29
- Exposure period:6hr
- Test groups:30
- Control group:10
- Site: 2 x 2 cm patch to the clipped skin of the right flank and covered with an occlusive dressing
- Concentrations:1%
- Evaluation (hr after challenge): 24 and 48hr

OTHER: All animals were observed daily for signs of systemic toxicity. Body weights were recorded on days 1 and 31.

2.not specified

Challenge controls:

1.yes, concurrent vehicle used
2.not specified

Positive control substance(s):

not specified

Reading:

other: 1. 1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

1%

No. with + reactions:

0

Total no. in group:

30

Clinical observations:

No skin sensitization reaction was observed.

Remarks on result:

no indication of skin sensitisation

Reading:

other: 2. 1st reading

Group:

test chemical

Dose level:

Not specified

No. with + reactions:

0

Clinical observations:

No skin sensitization reaction was observed.

Remarks on result:

no indication of skin sensitisation

No contact sensitization was observed in treated guinea pigs.

Interpretation of results:

other: Not sensitizing

Conclusions:

The test material was considered to be not sensitizing to the skin of treated guinea pigs.

Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical. The studies are as mentioned below:

The skin sensitization study of similar read across chemical was performed by Buehler test using 30 female Pirbright albino guinea pigs in treated group and 10 in control group. Doses were selected on the bases of preliminary study using 6 animals. In induction phase, induction given on day 1, using 4 % concentration in water by topical application as2 x 2 cm cellulose patch to the clipped skin of the left flank. The patch was covered with an occlusive dressing for 6 hours and removed afterwards. The second induction given on day 8 and third on day 15 using same procedure on day first. During the induction phase, the skin sites were examined for local effects 24 hours after each treatment. In challenge phase, on day 29 test substance 1% concentration in same vehicle applied on a 2 x 2 cm patch to the clipped skin of the right flank and covered with an occlusive dressing for 6 hour and evaluated 24 and 48hr after removal of occlusive dressing .All animals were observed daily for signs of systemic toxicity. Body weights were recorded on days 1 and 31.No skin sensitizing reaction observed after challenge application also no clinical effects were observed. Body weight development of the treated group was not different from that of the control group. During the induction phase, treated animals showed slight to well-defined erythema and very slight oedema at the treated skin area. After challenge, skin reactions were observed neither in the treated group nor in the control group. Hence the test chemical was considered to be not skin sensitizing in guinea pig.

 

Another Buhler test was conducted onfemalePirbrightalbinoguinea pigs to assess the skin sensitization potential of similar read across chemical. Doses were selected on the bases of preliminary study using 6 animals. In the preliminary study, 4% of test chemical in ethanol:water 80:20 as a concentration causing slight, well-defined erythema and very slight oedema and therefore suitable for induction. No irritation is reported after application of 1.0, 0.2 and 0.04%, wherefore 1% was used as challenge concentration.In the main study, the test group consisted of 20 female Guinea pigs and the control group of 10 female Guinea pigs. On day 1, a 4% solution of the test substance in ethanol was prepared and applied on a 2 x 2 cm cellulose patch to the clipped skin of the left flank. The patch was covered with an occlusive dressing for 6 hours and was removed afterwards. This treatment was repeated on days 8 and 15. During the induction phase, the skin sites were examined for local effects 24 hours after each treatment. On day 29 (challenge exposure) a 1% solution of the test substance in isopropanol was applied on a 2 x 2 cm patch to the clipped skin of the right flank and covered with an occlusive dressing for 6 hours. 24 and 48 hours after removal of the patches the skin reactions were scored. All animals were observed daily for signs of systemic toxicity. Body weights were recorded on days 1 and 31.During the study, no clinical effects were observed. Body weight development of the treated group was not different from that of the control group. During the induction phase, treated animals showed slight, well-defined to severe erythema and very slight to well-defined oedema at the treated skin area. After challenge, skin reactions were observed neither in the treated group nor in the control group.Thus on the basis of observed effects, the test chemical was considered to be not-sensitizing to the skin of guinea pigs.

 

The above results were further supported by a Buehler test conducted for another similar read across chemical on skin of guinea pigs. When the guinea pig were exposed to the test chemical, none of the treated animal had develop any allergic reaction. Hence the test material was considered to be not sensitizing to the skin of treated guinea pigs.

 

Based on the above summarized studies for target chemical and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical. The studies are as mentioned below:

The skin sensitization study of similar read across chemical was performed by Buehler test using 30 female Pirbright albino guinea pigs in treated group and 10 in control group. Doses were selected on the bases of preliminary study using 6 animals. In induction phase, induction given on day 1, using 4 % concentration in water by topical application as2 x 2 cm cellulose patch to the clipped skin of the left flank. The patch was covered with an occlusive dressing for 6 hours and removed afterwards. The second induction given on day 8 and third on day 15 using same procedure on day first. During the induction phase, the skin sites were examined for local effects 24 hours after each treatment. In challenge phase, on day 29 test substance 1% concentration in same vehicle applied on a 2 x 2 cm patch to the clipped skin of the right flank and covered with an occlusive dressing for 6 hour and evaluated 24 and 48hr after removal of occlusive dressing .All animals were observed daily for signs of systemic toxicity. Body weights were recorded on days 1 and 31.No skin sensitizing reaction observed after challenge application also no clinical effects were observed. Body weight development of the treated group was not different from that of the control group. During the induction phase, treated animals showed slight to well-defined erythema and very slight oedema at the treated skin area. After challenge, skin reactions were observed neither in the treated group nor in the control group. Hence the test chemical was considered to be not skin sensitizing in guinea pig.

 

Another Buhler test was conducted onfemalePirbrightalbinoguinea pigs to assess the skin sensitization potential of similar read across chemical. Doses were selected on the bases of preliminary study using 6 animals. In the preliminary study, 4% of test chemical in ethanol:water 80:20 as a concentration causing slight, well-defined erythema and very slight oedema and therefore suitable for induction. No irritation is reported after application of 1.0, 0.2 and 0.04%, wherefore 1% was used as challenge concentration.In the main study, the test group consisted of 20 female Guinea pigs and the control group of 10 female Guinea pigs. On day 1, a 4% solution of the test substance in ethanol was prepared and applied on a 2 x 2 cm cellulose patch to the clipped skin of the left flank. The patch was covered with an occlusive dressing for 6 hours and was removed afterwards. This treatment was repeated on days 8 and 15. During the induction phase, the skin sites were examined for local effects 24 hours after each treatment. On day 29 (challenge exposure) a 1% solution of the test substance in isopropanol was applied on a 2 x 2 cm patch to the clipped skin of the right flank and covered with an occlusive dressing for 6 hours. 24 and 48 hours after removal of the patches the skin reactions were scored. All animals were observed daily for signs of systemic toxicity. Body weights were recorded on days 1 and 31.During the study, no clinical effects were observed. Body weight development of the treated group was not different from that of the control group. During the induction phase, treated animals showed slight, well-defined to severe erythema and very slight to well-defined oedema at the treated skin area. After challenge, skin reactions were observed neither in the treated group nor in the control group.Thus on the basis of observed effects, the test chemical was considered to be not-sensitizing to the skin of guinea pigs.

 

The above results were further supported by a Buehler test conducted for another similar read across chemical on skin of guinea pigs. When the guinea pig were exposed to the test chemical, none of the treated animal had develop any allergic reaction. Hence the test material was considered to be not sensitizing to the skin of treated guinea pigs.

 

Based on the above summarized studies for target chemical and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The skin sensitization potential of test substance and its structurally and functionally similar read across substanceswere observed in various studies. From the results obtained from these studies it is concluded that the chemical is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.