Potassium iodide

Endpoint summary

Description of key information

In various studies, the test has been investigated for potential to cause skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in humans and guinea pigs for the target chemical as well as its structurally similar chemicals. 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:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Qualifier:

according to guideline

Guideline:

other: Patch test

Principles of method if other than guideline:

Patch-Test were performed to assess the dermal sensitization potential of the test chemical

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

not specified

Species:

other: humans

Strain:

not specified

Sex:

not specified

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

Ranging from 5 to 20 per cent

Adequacy of induction:

not specified

No.:

#1

Route:

epicutaneous, open

Vehicle:

petrolatum

Concentration / amount:

Ranging from 5 to 20 %

Adequacy of challenge:

not specified

No. of animals per dose:

Total 8 patients were tested

Details on study design:

no data available

Challenge controls:

no data available

Positive control substance(s):

not specified

Reading:

1st reading

Group:

test chemical

Dose level:

Concentrations ranging from 5 to 20 per cent in petrolatum

No. with + reactions:

3

Total no. in group:

8

Clinical observations:

In five of eight patients, the reactions were negative

Remarks on result:

no indication of skin sensitisation

Interpretation of results:

other: not sensitizing

Conclusions:

In five of eight patients, tested with the test chemical in concentrations ranging from 5 to 20 per cent in petrolatum, the reactions were negative for skin sensitisation.
Hence the test chemical was considered to be not sensitizing to skin.

Executive summary:

The Patch test was conducted to determine the dermal sensitization potential of the test chemical in humans. 8 patients were tested with the test chemical in concentrations ranging from 5 to 20 per cent in petrolatum, and observed for signs of contact sensitization (duration not specified). In five of eight patients tested with the test chemical, the reactions were negative for skin sensitization. Hence the test chemical was considered to be not sensitizing to skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

In various studies, the test has been investigated for potential to cause skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in humans and guinea pigs for the target chemical as well as its structurally similar chemicals. The results are summarized as follows:

 

The Patch test was conducted to determine the dermal sensitization potential of the test chemical in humans. 8 patients were tested with the test chemical in concentrations ranging from 5 to 20 per cent in petrolatum, and observed for signs of contact sensitization (duration not specified). In five of eight patients tested with the test chemical, the reactions were negative for skin sensitization. Hence the test chemical was considered to be not sensitizing to skin.

 

The skin sensitization study of similar read across chemical was performed by using Buehler test on 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.

 

The above results were further supported by the Guinea pig Maximization assay performed for another similar read across chemical. The study was performed as per EPA 540/9-82-025 Guidelines. 20 female Pirbright White guinea pigs were used for the study. 0.9% NaCl Solution was used as a vehicle. The following concentrations were used for the induction and challenge exposure- 1st: Induction 5 %, intracutaneous , 2nd: Induction 25 % , occlusive epicutaneous and 3rd: Challenge 10 %, occlusive epicutaneous. During the first phase of induction, intracutaneous injections were given to the test animals and injection sites were investigated till day 7. In day 9,0.5ml of the test substance preparation was applied to a cellulose patch of 2x4 cm. This patch covered the area of the intradermal injection sites. An occlusive dressing with impermeable foil and an elastic bandage sealed the application site for 48 hours. At the end of 48 hours of exposure, the occlusive bandages were removed and the test sites were observed for signs of erythema and edema. The animals were rested for 10-11 days then subjected to challenge exposure. 0.5ml of test substance preparation were applied to a cellulose patch and placed onto the clipped skin of the flank. An occlusive dressing with impermeable foil and an elastic bandage sealed the application site for 24 hours. 24 hours later the occlusive patches were removed and the test sites were assessed for dermal irritation. Ten percent of the animals of treatment group demonstrated a positive reaction after the challenge exposure (classification criteria – 30%). Hence, the test chemical was considered to be not sensitizing to skin.

 

Thus on the basis of results obtained in key and supportingstudies,it can be concluded that the testthe chemical is not able 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”.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The skin sensitization potential of test substance andits 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.