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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4 February 2003 to 29 April 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
At the time that the study was conducted the M&K method was considered to be the most widely accepted for worldwide regulatory purposes.

Test material

Constituent 1
Chemical structure
Reference substance name:
DL-serine
EC Number:
206-130-6
EC Name:
DL-serine
Cas Number:
302-84-1
Molecular formula:
C3H7NO3
IUPAC Name:
DL-serine
Test material form:
other: powder
Specific details on test material used for the study:
Batch number: 20017
Expiration date: 05 July 2003
Purity: 98,5%
Storage: In the original container, at room temperature (20+/-3°C), away from direct sunlight
Stability: Stable under storage conditions

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Ibm: GOHI; SPF
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 4-7 weeks
- Weight at study initiation: 296-364 g
- Housing: cages with standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard ad libitum
- Water (e.g. ad libitum): cummunity tap water ad libitum
- Acclimatization: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: Wate and an emulsion of Freund's Complete Adjuvant / physiological saline.
Concentration / amount:
40% dilution of the test item
Adequacy of induction:
highest technically applicable concentration used
Route:
other: epidermal induction
Vehicle:
water
Concentration / amount:
50% dilution of the test item
Day(s)/duration:
48 hours
Adequacy of induction:
other: Highest attainable concentration
Challenge
No.:
#1
Route:
other: epidermal application occlusive
Vehicle:
water
Concentration / amount:
50% concentration of the test item and purified water alone
Day(s)/duration:
24 and 48 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
test: 10
control: 5
Details on study design:
Main study:
Intradermal injections performed on test Day 1:
- test group:
1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
The test item at 40% in purified water.
The test item at 40% in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
Control group:
1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
Purified water.
1:1 (w/w) mixture of purified water in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
Epidermal application performed on test Day 8:
- Control and tet groups pre-treated with Sodium-Lauryl-Sulfate
- 50% in purified water placed over injection sites for test group and purified water for control group
Challenge controls:
- 2 weeks after the epidermal induction application
- 50% of concentration of the test substance and puriefied water applied on each flank
- Volume: 0.2mL
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
other: 24 hours
Hours after challenge:
24
Group:
other: Control group
Dose level:
test item at 50 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: 48 hours
Hours after challenge:
48
Group:
other: Control group
Dose level:
test item at 50 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: 24 hours
Hours after challenge:
24
Group:
test chemical
Dose level:
test item at 50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: 48 hours
Hours after challenge:
48
Group:
test chemical
Dose level:
test item at 50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: not a skin sensitiser
Conclusions:
Based on the above mentioned findings in an adjuvant sensitisation test (M&K-test) in guinea pigs the test substance does not have to be classified and labelled as a skin sensitiser.
Executive summary:

The skin sensitisation potential of the test material was investigated in a GLP study which was conducted in accordance with the standardised guideline OECD 406 following guinea pig maximisation test methods.

The intradermal induction was performed in the nuchal region with a 40% dilution of the test material in purified water and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal inductio of sensitisation was conducted for 48 hours under occlusion with the test material at 50% in purified water one week after the intradermal induction and following pretreatment of the test areas with 10% sodium lauryl sulphate (SLS) approximately 24 hours prior to application of the test material. The animals of the control group were intradermally induced with with purified water and FCA/physiological saline and epidermally induced with purified water under occlusion following pretreatment with 10% SLS.

Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test material at 50% in purified water and purified water alone under an occlusive dressing.

Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.

Under the conditions of the study no signs of toxicity were evident in the guinea pigs of the control or test group. No mortality occurred.

None of the control or test group animals showed skin reactions after challenge treatment with the test material at 50% w/w in purified water.

Based on the above mentioned findings in an adjuvant sensitisation test (M&K-test) in guinea pigs and in accordance to Commision Directive 96/54/EEC, the test substance does not have to be classified and labelled as a skin sensitiser.