4-(2-aminoethyl)phenol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

supporting 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 publication

Data source

Reference

Reference Type:

publication

Title:

The sensitization potential of some perfume ingredients tested using a modified draize procedure.

Author:

D.W. SHARP

Year:

1978

Bibliographic source:

Toxicology, 9 (1978) 261-271

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Skin sensitization study of Anisic alcohol (CAS No: 105-13-5) was conducted in 10 guinea pigs to determine its sensitization potential.

GLP compliance:

not specified

Type of study:

other: Modified DraizeTechnique

Justification for non-LLNA method:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

4-methoxybenzyl alcohol

EC Number:

203-273-6

EC Name:

4-methoxybenzyl alcohol

Cas Number:

105-13-5

Molecular formula:

C8-H10-O2

IUPAC Name:

(4-methoxyphenyl)methanol

Details on test material:

Name: 4-methoxybenzyl alcohol
InChI: 1S/C8H10O2/c1-10-8-4-2-7(6-9)3-5-8/h2-5,9H,6H2,1H3
Smiles:c1(ccc(OC)cc1)CO
- Molecular formula (if other than submission substance):C8H10O2
- Molecular weight (if other than submission substance):138.165 g/mol
- Substance type:Organic

Specific details on test material used for the study:

- Name of test material (as cited in study report): Anisic alcohol
- Molecular formula: C8H10O2
- Molecular weight: 138.165 g/mol
- Substance type: Organic
- Physical state: Liquid
-Smiles: c1(ccc(OC)cc1)CO
- InChI: 1S/C8H10O2/c1-10-8-4-2-7(6-9)3-5-8/h2-5,9H,6H2,1H3

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: albino Hartley

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS

- Weight at study initiation: 350 g
- Housing: Housed in wire mesh cages in pairs of the same sex
- Diet (e.g. ad libitum): Pelleted guinea pig diet, cabbage and hay ad libitum
- Water (e.g. ad libitum): water ad libitum

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

other: Yes suitable vehicle was used. (No detailed information )

Concentration / amount:

Induction concentration: 0.1 mL at 2.5 X 0.25(ICC) : 10 guinea pigs

Day(s)/duration:

No Data Available

Adequacy of induction:

other: The concentration giving slight but perceptible irritation with no oedema was selected as the injection challenge concentration (ICC).

Challenge

Challenge 1

No.:

#1

Route:

intradermal and epicutaneous

Vehicle:

other: Yes suitable vehicle was used. (No detailed information )

Concentration / amount:

Challenge concentration: 0.1 mL at 0.25 (ICC) and 10 (ACC): 10 guinea pigs

Day(s)/duration:

24 hours

Adequacy of challenge:

other: The concentration giving slight but perceptible irritation with no oedema was selected as the injection challenge concentration (ICC). The highest concentration which caused no irritation was selected as the application challenge concentration (ACC).

Challenge 2

No.:

#2

Route:

intradermal and epicutaneous

Vehicle:

other: Yes suitable vehicle was used. (No detailed information )

Concentration / amount:

Rechallenge concentration: 0.1 mL at 0.25(ICC) and 10 (ACC): 10 guinea pigs

Day(s)/duration:

24 hours

Adequacy of challenge:

other: The concentration giving slight but perceptible irritation with no oedema was selected as the injection challenge concentration (ICC). The highest concentration which caused no irritation was selected as the application challenge concentration (ACC).

No. of animals per dose:

10: 4 males and 6 females or visa versa.

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE: Intradermal
- No. of exposures:4
- Exposure period: No Data Available
- Test groups:10 guinea pigs
- Control group: No Data Available
- Site: 4 sites, 2 auxillary and 2 inguinal lymph nodes
- Frequency of applications:1
- Duration: No Data Available
- Concentrations: 0.1 mL at 2.5 X 0.25 (ICC)

B. CHALLENGE EXPOSURE: Intradermal and Epicutaneous
- No. of exposures:1
- Day(s) of challenge: Fourteen days later, challenge test was performed
- Exposure period:24 hours
- Test groups:10guinea pigs
- Control group: No Data Available
- Site: onto the shaved flank in a small circular area
- Concentrations: 0.1 mL at 0.25 (ICC) and 10 (ACC).
- Evaluation (hr after challenge):24 hours

C. RECHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge:7 Days Later , rechalleange test was performed.
- Exposure period: No Data Available
- Test groups:10 animal
- Control group: 4 animal (same sex)
- Site: Intradermally and topically on opposite flanks
- Concentrations: 0.1 mL at 0.25 (ICC) and 10 (ACC).
- Evaluation (hr after challenge): No Data Available

Challenge controls:

At each challenge with controls, 4 previously untreated animals of the same sex and similar weight to the test animals were treated intradermally and topically on opposite flanks with 0.1 ml aliquots of test substance at the ICC and ACC respectively.
Scoring.

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.1 mL at 0.25 (ICC) and 10 (ACC).

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

No skin sensitization was observed at tested concentrations.

Remarks on result:

no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:

No skin sensitization was observed at tested concentrations.

Applicant's summary and conclusion

Interpretation of results:

other: not sensitizing

Conclusions:

No signs of contact sensitization were observed at 0.25% ICC and 10% ACC concentrations. Hence the test material Anisic alcohol (CAS No: 105-13-5) was considered to be non-sensitizing to the skin of albino Hartley guinea pigs.

Executive summary:

The skin sensitization study ofAnisic alcohol (CAS No: 105-13-5)was carried out in 10 Inbred Hartley strain albino the guinea pigs of to determine its sensitization potential according modified Draize sensitization test.

 

The preliminary irritation tests were done in guinea pigs to determine concentrations suitable for sensitization testing [injection challenge concentration(ICC) and application challenge concentration(ACC) ]

 

In the induction phase,the total dose was administered on one occasion as 4 intradermal injections, each 2.5 times the ICC (2.5X 0.25). Fourteen days later each animal was challenged intradermally in one flank and topically in the other with 0.1 ml aliquots of test substance at the respective ICC and ACC (0.25 and 10 respectively). Twenty-four hours later the reactions were observed.

 

In the absence of sensitization reactions at first challenge the induction and challenge procedures were repeated, andapparent sensitization reactions confirmed 7 days later by a second challenge with controls included.

 

Based upon the second challenge, it can be concluded that theAnisic alcohol (CAS No: 105-13-5)was considered to be non-sensitizingto the skin of albino Hartley guinea pigs at 0.25% ICC and 10% ACC concentrations.