Dimethyloctadecyl(3-sulphopropyl)ammonium hydroxide

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

CBA/Ca

Remarks:

Mice CBA/CaOlaHsd

Sex:

female

Vehicle:

dimethylformamide

Concentration:

Pre-screen test: 25, 10 & 5 %w/v
Main test: 10, 5 & 2.5 %w/v

No. of animals per dose:

5

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Positive control results:

Valid, SI 13.53

Parameter:

SI

Value:

4.1

Test group / Remarks:

2.5%

Parameter:

SI

Value:

2.43

Test group / Remarks:

5%

Parameter:

SI

Value:

5.94

Test group / Remarks:

10%

Parameter:

EC3

Value:

4.1

Test group / Remarks:

5%

Parameter:

EC3

Value:

5.81

Test group / Remarks:

10%

Cellular proliferation data / Observations:

CELLULAR PROLIFERATION DATA
2.5 %: 11622
5 %: 6882
10%: 16839

EC3 CALCULATION
Estimated concentration of a test substance needed to produce a stimulation index of three. EC3 value is determined by linear interpolation of points on dose-response curve, immediately above and below of SI value, according to the equation:
EC3=c+[(3-d)/(b-d)]x(a-c)
a – higher concentration, b – SI of higher concentration, c – lower concentration, d – SI of lower concentration
If all points are below the stimulation index of three, no EC3 value can be stated.


CLINICAL OBSERVATIONS:
Daily clinical observation of animals did not show visible clinical signs of systemic toxicity in all treated mice

BODY WEIGHTS
No effects on body weights in all treated mice

SIGNS OF TOXICITY (including dermal irritation at the site of administration, if any, e.g. increased ear thickness).
No signs of significant local irritation were observed in test item treated groups. Slight vascular drawing was visible on ears of in high dosed group of mice (high dose group 10 %) on days 2-3. At the application site, white precipitates were observed at the ends of the ears.

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

Conclusions:

Based on the EC3 value of 5% the test item is considered a skin sensitizer. According to the ECETOC classification, test item is classified as moderate allergen.

Executive summary:

The sensitization potential of the test item was evaluated using Local Lymph Node Assay (LLNA) accoridng to OECD 429. Based on the observation in the Pre-screen test, the concentrations of 10 %, 5 % and 2.5 % (w/v) were selected for the Main study. Five female mice (CBA/CaOlaHsd) per group were topically exposed (dorsum of both ears) to the test item at concentrations. Lymphocyte proliferation was measured using incorporation of radioactive 3H-methyl-thymidine in the draining lymph nodes. The radioactive incorporation was measured as disintegrations per minute (DPM). Results were expressed as Stimulation Index (SI) calculated as DPM/pooled treatment group divided by DPM/vehicle control group.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Justification for classification or non-classification

Based on the results from the LLNA study, the test substance is classified as Skin sensitization 1, H317 May cause an allergic skin reaction.