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Diss Factsheets

Administrative data

Description of key information

The test material was sensitizing to skin in the GPMT Assay according to OECD Guideline 406 performed under GLP conditions.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 14 until December 15, 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
July 1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The GPMT Assay was conducted before the LLNA Assay became mandatory.
Species:
guinea pig
Strain:
other: IVA : PDH
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Kisslegg
- Age at study initiation: about 4 weeks
- Weight at study initiation: 338 to 424 g
- Housing: individually in Makrolon cages type IV (floor area: 55 x 33 cm = 1815 cm2, height: 20 cm) placed an mobile racks.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 28
- Humidity (%): 31 - 63
- Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal
Vehicle:
paraffin oil
Concentration / amount:
0.5%
Day(s)/duration:
Day 1
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
20%
Day(s)/duration:
Day 8/ 48 hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
5.0%
Day(s)/duration:
Day 22/24 hours
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
5.0%
Day(s)/duration:
Day 29/ 24 hoours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
5 animals per sex and per dose (negative control)
10 animals per sex and per dose (positive control)
Details on study design:
RANGE FINDING TESTS: The follwoing concentrations were used:
1. Vehicle (intradermal): undiluted
2. Test material (intradermal): 2.5%, 1.0%, and 0.5% in liquid paraffin
3. Test material (topical): 25.0, 15.0, 10.0, and 5.0% in liquid paraffin

Based on the results of the pre-test the follwoing concentrations were used for the main test:
- intradermal induction: 0.5% (slightly irritant)
- topical induction: 20.0% (slightly irritant)
- topical challenge: 5.0% (not irritant)

MAIN STUDY
A.1 INDUCTION EXPOSURE (intradermal injection)
- No. of exposures: six (three on each side of the spinal column)
- Test groups: FCA + phys. sodium chloride solution; 0.5% test material in liquid paraffin; FCA with test material (0.5 g ad 100 mL completed preparation) + phys. sodium chloride solution
- Control group: FCA + phys. sodium chloride solution; liquid paraffin; FCA + phys. sodium chloride solution
- Site: shoulder
- Frequency of applications: once

A.2 INDUCTION EXPOSURE (topical application)
- No. of exposures: one
- Exposure period: 48 hours
- Test groups: 20% test material in liquid paraffin
- Control group: liquid paraffin (undiluted)
- Site: shoulder
- Frequency of applications: once
- Concentrations: 20% test material in liquid paraffin

B. CHALLENGE EXPOSURE
- No. of exposures: two
- Day(s) of challenge: first challenge on day 22; second challenge on day 29
- Exposure period: 24 hours
- Test groups: 5% test material in liquid paraffin (left side); undiluted liquid paraffin (right site)
- Control group: 5% test material in liquid paraffin (left side); undiluted liquid paraffin (right site)
- Site: flank
- Evaluation (hr after challenge): 48 and 72 hours
Positive control substance(s):
yes
Remarks:
1-Chloro-2,4-dinitrobenzene (positive control data from study T 13982 performed from Nov 14 until Dec 15, 1995)
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No clinical and no mortality occurred. Body weight gain was normal.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No clinical and no mortality occurred. Body weight gain was normal.
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
5.0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No clinical and no mortality occurred. Body weight gain was normal.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
5.0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No clinical and no mortality occurred. Body weight gain was normal.
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5.0%
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
No clinical and no mortality occurred. Body weight gain was normal.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
5.0%
No. with + reactions:
7
Total no. in group:
20
Clinical observations:
No clinical and no mortality occurred. Body weight gain was normal.
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No clinical and no mortality occurred. Body weight gain was normal.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0%
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
No clinical and no mortality occurred. Body weight gain was normal.
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No clinical and no mortality occurred. Body weight gain was normal.
Key result
Reading:
rechallenge
Hours after challenge:
72
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No clinical and no mortality occurred. Body weight gain was normal.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
5.0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No clinical and no mortality occurred. Body weight gain was normal.
Key result
Reading:
rechallenge
Hours after challenge:
72
Group:
negative control
Dose level:
5.0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No clinical and no mortality occurred. Body weight gain was normal.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
5.0%
No. with + reactions:
9
Total no. in group:
20
Clinical observations:
No clinical and no mortality occurred. Body weight gain was normal.
Key result
Reading:
rechallenge
Hours after challenge:
72
Group:
test chemical
Dose level:
5.0%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
No clinical and no mortality occurred. Body weight gain was normal.
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
No clinical and no mortality occurred. Body weight gain was normal.
Key result
Reading:
rechallenge
Hours after challenge:
72
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No clinical and no mortality occurred. Body weight gain was normal.
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.01% DNCB
No. with + reactions:
10
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
positive control
Dose level:
0.01% DNCB
No. with + reactions:
10
Total no. in group:
10
Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
The test item is considered to be sensitizing to skin based on the results of the GLP conform study according to OECD Guideline 406.
Executive summary:

The test item was studied for skin sensitizing properties in the guinea-pig maximization test according to OECD Guideline 406 under GLP conditions.

5 males and 5 females in the negative control group (group 1) and 10 males and 10 females in the test material group (group 2) were investigated.

Induction included intradermal injection of the test material (0.5 % without and with Freund's complete adjuvant) on day 1, and topical application of the test material (20.0 %) on day 8 of the study. Challenge by topical application of the test material (5.0%) was performed two weeks after topical induction (challenge I). Two animals of group 2 after the first challenge reacted on both sites. Therefore, a second challenge was performed (challenge II) one week later to clarify this result.

Group 1: negative control group

Following challenge I and challenge II no positive reactions in the treated areas were observed.

Group 2: test material group

With paraffin alone, 2 of 20 animals after challenge I and 3 of 20 animals after challenge II showed positive reactions. Topical challenge with the test item was performed with a 5.0 % preparation. After challenge I, positive reactions in the treated areas were observed in 7 of 20 animals (35 %). After challenge II, 10 of 20 animals (50 %) showed positive reactions.

Based on the available data, the test item has to be considered as skin sensitizer.

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data, the test item is classified as skin sensitizer Cat. 1 and labelled with H317 according to Regulation (EC) No 1272/2008.