2-Propenamide, N-(2-hydroxyethyl)-

Endpoint summary

Description of key information

Skin sensitisation:

The test item HEAA does not show an allergenic potential when tested up to concentration of 10% w/v.

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

Study period:

7 April 2004 to 21 April 2004

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)

Specific details on test material used for the study:

Batch number: 031128
Purity: 99%

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan, Netherlands, B.V. Postbus 6174, NL-5960 AD Horst, The Netherlands
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 20.2 - 20.7g
- Housing:individual in Makrolon type-2 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132, Muttenz).
- Diet: pelleted standard Kliba 3433, batch no. 78/03 mouse maintanace diet (Provimi Kliba AG, CH-4303 Kaiseraugst), avaliable ad libitum.
- Water:Community tap water from Itingen, avaliable ad libitum.
- Acclimation period: Under test conditions after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light / 12 hours dark cycle with at least 8 hours music during the light period.

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

2.5, 5 and 10% w/v

No. of animals per dose:

4

Details on study design:

RANGE FINDING TESTS:
To determine the highest non-irritant and technically applicable test item concentration, a non-GLP pretest was performed in two mice with concentrationss of 5, 10, 25 and 50% w/v. The test item in main study was assayed at three consecutive concentrations. The top dose is the highest technically applicable concentration whilst avoiding systemic toxicity and excessive local irritation.

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT:
Each test group of mice was treated by topical application to dorsal surface of each ear lobe with different test item concentrations of 2.5%, 5% and 10%, once daily for three consecutive days.
Five days after the first topical application, all mice were admistered with 250 uL of 3HTdR by intravenous injection via a tail vein.
Approximately five hours after treatment with 3HTdR all mice were euthanized by inhalation of CO2. The level of 3HTdR incorporation was then measured.

Criteria used to consider a positive response:
First, the exposure to at least one concentration of test item resulted in an incorporation of 3HTdR at leasst 3-fold or greater than that recorded in control mice; Second, the data are compatible with conventional dose response, although allowance must be made for either local toxicity or immunological suppression.

Positive control substance(s):

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

Positive control results:

The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured on a ß-scintillation counter.


Test item concentration % (w/v) S.I.
Group 2 5 1.5
Group 3 10* 2.3*
Group 4 25* 8.4*
EC3 = 11.7% (w/v)
A clear dose-response was observed
*This value was used in calculation of EC3

No deaths occurred during the study period.

No clnical signs were observed in any animals of the control group, Group 2 (5%) or Group 3 (10%). Approximately 90 minutes after the first topical application, a slight ear erythema was observed at both dosing sites in all mice of Group 4 (25%).

The body weight of the animals, recorded prior to the 1st application and prior to necropsy, was within the range, commonly recorded for animals of this strain and age.

Key result

Parameter:

SI

Value:

0.5

Test group / Remarks:

2.5% w/v test item

Key result

Parameter:

SI

Value:

0.5

Test group / Remarks:

5% w/v test item

Key result

Parameter:

SI

Value:

0.6

Test group / Remarks:

10% w/v test item

Cellular proliferation data / Observations:

CLINICAL OBSERVATIONS:
No deaths occurred during the study period.
No clinical signs were observed in any animals of the control group, 2.5% or 5% group. On the third application day, a slight ear erythema was observed at both dosing sites in all mice of 10% group.

BODY WEIGHTS:
The body weight of the animals, recorded prior to the 1st application and prior to necropsy, was within the range commonly recorded for animals of this strain and age.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item HEAA does not show an allergenic potential when tested up to concentration of 10% w/v.

Executive summary:

The study was performed to assess skin sensitisation potential of HEAA to mice with LLNA assay, according to OECD Guideline 429, under GLP.

The test item HEAA does not show an allergenic potential when tested up to concentration of 10% w/v.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The study was performed to assess skin sensitisation potential of HEAA to mice with LLNA assay, according to OECD Guideline 429, under GLP.

The test item HEAA does not show an allergenic potential when tested up to concentration of 10% w/v.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Skin sensitisation:

LLNA study give negative result with SI value of 0.6.

According to Regulation (EC) No 1272/2008, table 3.4.2, this substance should not be classified for this endpoint.