Ethyl N-hydroxyacetimidate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data from handbook or collection of data

Data source

Reference

Reference 1

Reference Type:

review article or handbook

Title:

determination of Skin sensitization for CAS no: 3710-84-7

Author:

HSDB

Year:

2017

Bibliographic source:

U.S. National Library of Medicine National Institutes of Health, Health & Human Services; 2017.

Reference 2

Reference Type:

secondary source

Title:

Robust Summary & Test Plans: Diethylhydroxylamine: Robust Summary

Author:

IUCLID Dataset-OECD SIDS

Year:

2006

Bibliographic source:

Robust Summary & Test Plans: Diethylhydroxylamine: Robust Summary; IUCLID Dataset-OECD SIDS; 2006 JANURY 13.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

A Buehler test was conducted on male guinea pigs to assess the skin sensitization potential of chemical N,N-Diethylhydroxylamine (CAS no: 3710-84-7) .

GLP compliance:

not specified

Type of study:

Buehler test

Justification for non-LLNA method:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

N,N-Diethylhydroxylamine

Cas Number:

3710-84-7

Molecular formula:

C4H11NO

IUPAC Name:

N,N-Diethylhydroxylamine

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): - N,N-Diethylhydroxylamine
Molecular formula: C4H11NO
- Molecular: 89.1369 g/mol
- Substance type: Organic
- Physical state: Liquid
- InChI: 1S/C4H11NO/c1-3-5(6)4-2/h6H,3-4H2,1-2H3
- Smiles: N(CC)(CC)O

Specific details on test material used for the study:

- Name of test material (as cited in study report): - N,N-Diethylhydroxylamine
Molecular formula: C4H11NO
- Molecular: 89.1369 g/mol
- Substance type: Organic
- Physical state: Liquid
- InChI: 1S/C4H11NO/c1-3-5(6)4-2/h6H,3-4H2,1-2H3
- Smiles: N(CC)(CC)O

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

male

Details on test animals and environmental conditions:

- Age at study initiation: young adult

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

other: deionized water

Concentration / amount:

30%

Day(s)/duration:

3 weeks

Adequacy of induction:

other: the highest non-irritating dose concentration

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

other: deionized water

Concentration / amount:

30%

Day(s)/duration:

48 hours

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

15 guinea pigs

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 48 hours
- Test groups: 10
- Control group: no data available
- Site: no data
- Frequency of applications: on alternate days until a total of nine dose applications was achieved
- Duration: 3 weeks
- Concentrations: 30%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 17 days
- Exposure period: 48 hours
- Test groups: 10
- Control group: 5
- Site: naive site
- Concentrations: 30%
- Evaluation (hr after challenge): 24 and 48 hours

Challenge controls:

A naive control group of five animals was maintained under the same environmental conditions and was treated with the test material at challenge only.

Positive control substance(s):

yes

Remarks:

0.08% Dinitrochlorobenzene (DNCB) in 95% ethyl alcohol

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

30%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

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.

Remarks on result:

no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:

INDUCTION PHASE :
. Test Animals: By the 4th induction many animals exhibited very mild erythema at both 24 and 48 hours post-dose. A slight increase in the severity of irritation was noted at several sites after inductions 8 and 9.

. Positive Control Animals (0.08% DNCB): Varying degrees of erythema were observed throughout induction, increasing in severity toward the end of this period.


CHALLENGE PHASE:
. Test Animals: No irritation was noted after challenge.

. Naive Control Animals: No irritation was noted after challenge.

. Positive Control Animals (0.08% DNCB): Twenty-four and 48 hours after challenge all sites were erythemic, showing a faint to moderate response. The incidence and severity of irritation.

Any other information on results incl. tables

Hours	Sensitization Response
	Incidence		Severity
	24 hours	48 hours	24 hours	48 hours
Test animal	0/10	0/10	0	0
Positive control animals	0/10	0/10	1.5	0.85
Naive Animals	0/5	0/5	0	0

Applicant's summary and conclusion

Interpretation of results:

other: not sensitizing

Conclusions:

The chemical N,N-Diethylhydroxylamine (CAS no: 3710-84-7) was considered to be not-sensitizing to the skin of guinea pigs in a Buehler test.

Executive summary:

A Buehler test was conducted on male guinea pigs to assess the skin sensitization potential of chemical N,N-Diethylhydroxylamine (CAS no: 3710-84-7) .

 

After establishing the highest non-irritating dose concentration, a 3 week induction period was initiated during which 10 young adult, male, guinea pigs were treated with the test material applied as a 30% w/w solution in deionized water and 10 were treated with 0.08% Dinitrochlorobenzene (DNCB) in 95% ethyl alcohol (positive controls). During the induction period the animals were dosed on alternate days until a total of nine dose applications were achieved. Seventeen days after the nine application a challenge dose was applied to a naive site on each guinea pig and approximately 24 and 48 hours 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 was treated with thewith the test material at challenge only.

 

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.

 

After 24 and 48 hours, all sites were erythemic, showing a faint to moderate response but no irritation was observed in test and naive groups after challenge. Hence thechemicalN,N-Diethylhydroxylamine (CAS no: 3710-84-7) was considered to be not-sensitizing to the skin of guinea pigs in a Buehler test.