3-(D-gluconoylamino)propyl(2-hydroxyethyl)dimethylammonium chloride

Endpoint summary

Description of key information

The key information is based on a test performed according to the Landsteiner and Jacobs Guinea Pigs Sensitization Procedure, essentially similar to the Buehler test.

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

Study period:

July 5 - August 10, 1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

Essentially similar to the Buehler test.

Deviations:

yes

Remarks:

Number of animals < 20 and multiple injections instead of only one.

Principles of method if other than guideline:

Landsteiner and Jacobs Guinea Pigs Sensitization Procedure

GLP compliance:

no

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Study is performed before introduction of the LLNA method as a sensitization study.

Specific details on test material used for the study:

Not specified

Species:

guinea pig

Strain:

not specified

Sex:

male

Details on test animals and environmental conditions:

A group of 10 white male guinea pigs weighing300-500 grams were identified and housed individually.
The hair was removed from their backs with an electric clipper prior to initiation of study and whenever necessary throughout the study.
They subsisted on commercial rabbit pellets, greens, carrots and water.

Route:

intradermal

Vehicle:

physiological saline

Concentration / amount:

0.1% solution

Day(s)/duration:

Injections were performed three times weekly, until a total of ten had been made.

Adequacy of induction:

not specified

Route:

intradermal

Vehicle:

physiological saline

Concentration / amount:

0.1% solution

Day(s)/duration:

Two weeks ajter the tenth injection, a challenge (re-test) injection was performed, using 0.05 ml. of a freshly prepared solution or suspension.

Adequacy of challenge:

not specified

No. of animals per dose:

10

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: three weeks
- Test groups: 1
- Control group: no
- Site: at random in the shaved back areas
- Frequency of applications: three times weekly
- Concentrations: 0.1 % solution
- Evaluation (hr after injection): 24 h

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Two weeks ajter the tenth injection
- Site: The eleventh (re-test) injection was made just below the region of the ten sensitizing injections.
- Evaluation (hr after challenge): 24 h

Challenge controls:

Not included

Positive control substance(s):

not required

Positive control results:

Not included

Key result

Reading:

other: Average of Ten Sensitizing injections

Hours after challenge:

24

Group:

test chemical

Dose level:

0.1%

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

no indication of skin sensitisation

Key result

Reading:

rechallenge

Hours after challenge:

24

Group:

test chemical

Dose level:

0.1%

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

no indication of skin sensitisation

Interpretation of results:

GHS criteria not met

Conclusions:

1) The test material, when intra-cutaneously injected produced scores identical to that of the control (distilled water).
2) On the challenge (re-test) injection, none of the test animals exhibited reactions higher than the average of the original scores.
3} The test material is considered to be a non-sensitizer (score 0. 0).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Justification for classification or non-classification

The test material, when intra-cutaneously injected produced scores identical to that of the control (distilled water). On the challenge (re-test) injection, none of the test animals exhibited reactions higher than the average of the original scores. In conclusion, the test material is considered to be a non-sensitizer.