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EC number: 201-487-4 | CAS number: 83-56-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-12-01 to 2004-05-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- draft June 2001
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- March 2003
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Naphthalene-1,5-diol
- EC Number:
- 201-487-4
- EC Name:
- Naphthalene-1,5-diol
- Cas Number:
- 83-56-7
- Molecular formula:
- C10H8O2
- IUPAC Name:
- naphthalene-1,5-diol
- Reference substance name:
- unknown
- Molecular formula:
- none
- IUPAC Name:
- unknown
Constituent 1
impurity 1
- Specific details on test material used for the study:
- Vehicle
Acetone/Olive oil (4:1 v/v)
Rationale
The vehicle was selected as suitable vehicle at request of the sponsor and based on trial formulations perlormed at NOTOX.
Preparation
The test substance formulations (w/w) were prepared within 4 hours prior to each treatment. No adjustment was made for specific gravity of the vehicle. Homogeneity was obtained to visually acceptable levels.
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Species
Mouse, CBA strain, inbred, SPF-Quality.
Recognised by the international guidelines as the recommended test system (e.g. OECD, EC, EPA)
Source: Charles River France, L'Arbresle Cedex, France
Number of animals
30 females (six groups of five females each group).
(nulliparous and non-pregnant).
Age and bodyweight
Young adult animals (approx. 10 weeks old) were selected. Body weight variation for the majority of animals was within +/- 20% of the sex mean. The body weights of six animals were outside the range of 21 ± 4 grams.
Identification
Tailmark.
Control animals
The results of the vehicle control animals in NOTOX Project 398058 were used as reference for the initially treated animals of this study and the results of the vehicle control animals, treated in NOTOX Project 401028 were used as reference for the additional treated animals of this study.
The vehicle control animals were treated using the same vehicle, using the same procedures and within the same time frame as this study. The control animals used for the initially treated animals were 14 weeks old and were considered suitable to be used as controls for this study.
Reliability check
The results of a reliability test performed not more than 6 months previously or 2 months afterwards are summarised in the Appendix. Similar procedures were used in the reliability test and in this study.
Animal husbandry
Conditions
Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 ± 3.0°C (actual range: 17.9 - 21.6°C), a relative humidity of 30-70% (actual range: 29 - 70%) and 12 hours artificial fluorescent light and 12 hours darkness per day.
Accommodation
Individual housing in labelled Macrolon cages (type I; height 12.5 cm) containing purified sawdust as bedding material (Woody-Clean type 3/4; Tecnilab-BMI BV, Someren , The Netherlands). Certificates of analysis were examined and then retained in the NOTOX archives. The acclimatisation period was at least 5 days before the start of treatment under laboratory conditions. Animals were group housed in polycarbonate cages (Macrolon II type; height 15 cm) during the acclimatisation period.
Diet
Free access to standard pelleted laboratory animal diet (from Altromin (code VRF 1), Lage, Germany). Certificates of analysis were examined and then retained in the NOTOX archives.
Water
Free access to tap-water. Certificates of quarterly analysis were examined and then retained in the NOTOX archives.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0.25 - 1 - 2.5 - 5 - 25 - 50%
- No. of animals per dose:
- 5
- Details on study design:
- Preliminary irritation study
A preliminary irritation study was conducted in order to select the highest test substance concentration to be used in the main study. In principle, this concentration should be well tolerated systemically by the animals and may give moderate irritation (grade 3) at the highest.
A series of four test substance concentrations were tested, the highest concentration being the maximum concentration that could technically be applied. The starting- and subsequent concentrations were taken from the series: 100% (undiluted), 50%, 25%, 10%, 5%,2.5%, 1% and if needed further lower concentrations using the same steps. The test system, procedures and techniques were identical to those used during days 1 to 3 of the main study unless otherwise specified.
Four young adult animals were selected (5-14 weeks old). Each animal was treated with one concentration on two consecutive days. Approximately 4 hours after the last exposure, the skin was cleaned of residual test substance with water and the irritation was assessed. No necropsy was performed and no bodyweights were determined after termination.
Main study
Initially, three groups of five animals were treated with three test substance concentrations respectively.
Based on the results, three additional groups were treated with three lower concentrations.
INDUCTION
GROUP* INDUCTION
5 (21-25) Experimental Lowest test substance concentration: 5%
6 (26-30) Experimental Intermediate test substance concentration: 25%
7 (31-35) Experimental HiQhest test substance concentration: 50%
*. five females each group, animal numbers between brackets Allocation additional groups
GROUP* INDUCTION
8 (36-40) Experimental test substance concentration: 0.25%
9 (41-45) Experimental test substance concentration: 1.0%
10 (46-50) Experimental test substance concentration: 2.5%
*. five females each group, animal numbers between brackets
INDUCTION - Days 1, 2 and 3
Experimental animals:
The dorsum surface of both ears was epidermally treated (25 µg/ear) with the test substance concentration, approximately the same time each day.
TREATMENT - Day 6:
All animals:
Each animal was injected via the tail vein with 0.25 ml of sterile phosphate buffered saline (PBS) containing 20 !-µCi of 3H-methyl thymidine (Amersham Pharmacia Biotech, NOTOX Substance 105624).
After approximately five hours, all animals were killed by intra peritoneal injection with an overdose of pentobarbital. The draining (auricular) Iymph node of each ear was excised.
The relative size of the nodes (as compared to normal) was estimated by visual examination and abnormalities of the nodes were recorded. The nodes were pooled for each animal in 3 ml PBS.
6.6. Tissue processing for radioactivity
A single cell suspension of Iymph node cells (LNC) was prepared in PBS by gentle separation through stainless steel gauze (diameter 125 µm). LNC were washed twice with an excess of PBS by centrifugation at 200g for 10 minutes at 4°C. The DNA was precipitated with 3 ml 5% trichloroacetic acid (TCA) at 4° C for approximately 18 hours.
Precipitates were recovered by centrifugation at 200g for 10 minutes, resuspended in 1 ml TCA and transferred to 10 ml of Ultima Gold (Packard) as the scintillation fluid.
6.7. Radioactivity measurements
All radioactive measurements were performed using a Packard scintillation counter (1900TR).
Counting time was to a statistical precision of ± 0.2% or a maximum of 5 minutes whichever comes first. The Packard 1900TR was programmed to automatically subtract background and convert CPM to DPM.
Observation
Mortality/Viability
Twice daily.
Toxicity
At least once daily.
Body weights
On days 1 (pre-treatment) and 6.
Irritation
On day 3 (3-4 hours after treatment), the skin reactions were assessed. If possible, skin reactions were graded according to the following numerical scoring system. Furthermore, descriptions of all other (Iocal) effects were recorded.
Grading Irritation Reactions:
Erythema and eschar formation:
No erythema ...................................................................................................................................... 0
Slight erythema (barely perceptible) ................................................................................................... 1
Well-defined erythema ....................................................................................................................... 2
Moderate erythema .......................................................................................................................... 3
Severe erythema (beet redness) 10 slight eschar formation (injuries in depth) ..................................... .4
Oedema formation:
Nooedema ........................................................................................................................................ 0
Slight oedema (barely perceptible) ...................................................................................................... 1
Well-defined oedema (edges of area well-defined by definite raising) .................................................. 2
Moderate oedema (raised approximately 1 millimeter) .......................................................................... 3
Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure) ................. 4 - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- A reliability check is carried out at regular intervals to check the sensitivity of the test system and the reliability of the experimental techniques as used by NOTOX. In this study, performed in March 2004, females ofthe CBA mouse strain (from Charles River France, L'Arbresle Cedex, France) were checked for the sensitivity to ALPHA-HEXYLCINNAMICALDEHYDE, TECH. 85%.
The females were apprax. 10 weeks old at commencement of the study. The study was based on the OECD Guideline No. 429, the EC Directive 67/548/EC, Part 8.42 and on the method described by ICCVAM (NIH publication; No 99-4494, February 1999). ALPHAHEXYLCINNAMICALDEHYDE, TECH. 85% (CAS no. 101-86-0) was fabricated under lot no. 10021 HF (Aldrich Chemicals Co., Germany). Concentrations used for this study were 5, 10 and 25% in Acetone:Olive oil (4:1).
CONCLUSION
The SI values calculated for HCA concentrations 5, 10 and 25% were 1.2, 2.7 and 16.8 respectively.
An EC3 value of 10.3% was calculated using linear interpolation.
The calculated EC3 value was found to be in the acceptable range of 2 and 20%.
Based on these results it was concluded that the Local Lymph Node Assay as performed at NOTOX is an appropriate model for testing for contact hypersensitivity.
The raw data, protocol and report from this study are kept in the NOTOX archives. The test described above was performed in accordance with NOTOX Standard Operating Procedures and the report was audited by the QA-unit.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- EC3
- Value:
- 3.4
- Parameter:
- SI
- Value:
- 1.4
- Test group / Remarks:
- 8
- Parameter:
- SI
- Value:
- 2.5
- Test group / Remarks:
- 9
- Parameter:
- SI
- Value:
- 2.8
- Test group / Remarks:
- 10
- Parameter:
- SI
- Value:
- 18.4
- Test group / Remarks:
- 5
- Parameter:
- SI
- Value:
- 16.7
- Test group / Remarks:
- 6
- Parameter:
- SI
- Value:
- 6.1
- Test group / Remarks:
- 7
Any other information on results incl. tables
PRELIMINARY IRRITATION STUDY
The results of the epidermal exposures for the selection of highest test substance concentration to be tested in the main study are described in Table 1.
Based on the results, the test highest test substance concentration selected for the main study was a 50% concentration.
MAIN STUDY
Induction phase (Table 2)
The skin effects seen after the third epidermal exposure are presented in the table.
Macroscopy (Table 2)
The sizes of the majority of nodes were considered to be normal, except for a few nodes among the experimental animals. No other macroscopic abnormalities of the nodes were noted.
Body Weights (Table 2)
Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. The slight body weight loss, noted in some animals, was considered not toxicologically significant.
Radioactivity Measurements (Table 3)
Mean DPM/animal values for the experimental groups treated with test substance concentrations 5, 25 and 50% were 2784,2522 and 921 respectively. The mean DPM/animal value for the vehicle contra I group was 151 (NOTOX Project 398058).
In order to clarify the dose response relationship, additional groups of animals were treated with test substance concentrations 0.25, 1 and 2.5% were 363,656 and 745 respectively. The mean DPM/animal value for the vehicle control group was 262 (NOTOX Project 401028).
ToxicityIMortality
No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.
PRELIMINARY IRRITATION STUDY
Table 1: Grading of Skin Reactions after Epidermal Exposure
Day1 dorsal surface ear (Day2)
animal Body cone.% left right
number |
weight (g) |
|
erythema |
oedema |
erythema |
oedema |
1 |
23 |
5 |
0 |
0 |
0 |
0 |
2 |
24 |
10 |
0 |
0 |
0 |
0 |
3 |
22 |
25 |
0 |
0 |
0 |
0 |
4 |
23 |
50 |
0 |
0 |
0 |
0 |
Note: The 50% concentration was applied using a spatula, instead of using a pipette.
MAIN STUDY
Table 2: Skin reactions after 3rd induction, Body Weights and Relative Size Nodes
|
Da;t1 |
Da;t3 |
|
Da;t6 |
||
group |
an |
|
bw |
skin grading dorsal surface ear |
bw |
size nodes |
treatment |
no |
|
(g) |
left right |
(g) |
left right |
erythema oedema erythema oedema
1 |
1 |
22 |
0 |
0 |
0 |
0 |
21 |
n |
n |
Vehicle• |
2 |
26 |
0 |
0 |
0 |
0 |
25 |
n |
n |
Control |
3 |
23 |
0 |
0 |
0 |
0 |
22 |
n |
n |
|
4 |
23 |
0 |
0 |
0 |
0 |
20 |
n |
n |
|
5 |
26 |
0 |
0 |
0 |
0 |
23 |
n |
n |
5 |
21 |
23 |
0 |
0 |
0 |
0 |
22 |
n |
n |
5% test |
22 |
22 |
0 |
0 |
0 |
0 |
23 |
n |
n |
substance |
23 |
17 |
0 |
0 |
0 |
0 |
18 |
n |
n |
|
24 |
20 |
0 |
0 |
0 |
0 |
22 |
n |
n |
|
25 |
23 |
0 |
0 |
0 |
0 |
23 |
n |
n |
6 |
26 |
19 |
0 |
0 |
0 |
0 |
19 |
n |
n |
25% test |
27 |
24 |
0 |
0 |
0 |
0 |
23 |
+ |
+ |
substance |
28 |
22 |
0 |
0 |
0 |
0 |
22 |
n |
n |
|
29 |
22 |
0 |
0 |
0 |
0 |
23 |
+ |
+ |
|
30 |
26 |
0 |
0 |
0 |
0 |
26 |
n |
n |
7 |
31 |
24 |
0 |
0 |
0 |
0 |
24 |
n |
n |
50% test |
32 |
25 |
0 |
0 |
0 |
0 |
25 |
n |
n |
substance |
33 |
22 |
0 |
0 |
0 |
0 |
19 |
n |
n |
|
34 |
22 |
0 |
0 |
0 |
0 |
22 |
n |
n |
|
35 |
27 |
0 |
0 |
0 |
0 |
27 |
n |
n |
Legends: BW =Bodyweight, Relative size nodes(-: reduced,+: enlarged, n: considered to be normal)
• Acetone/Olive oil (4:1 v/v) (NOTOX Project398058)
Note 1: The 50% concentration was applied using a spatula, instead of using a pipette.
Note 2: Body weights of animals 2, 5, 30 and 35 exceeded the weight range of 21 ± 4 grams.
Table 3: Skin reactions after 3rd induction, Body Weights and Relative Size Nodes (cont'd)
|
Da 1 |
Da 3 |
|
Da 6 |
|
group |
an |
bw |
skin grading dorsal surface ear |
bw |
size nodes |
treatment |
no |
(g) |
left right |
(g) |
left right |
erythema oedema erythema oedema
ADDITIONAL GROUPS
1 |
1 |
22 |
0 |
0 |
0 |
0 |
22 |
n |
n |
Vehicle* |
2 |
21 |
0 |
0 |
1 |
0 |
21 |
n |
n |
Control |
3 |
19 |
0 |
0 |
1 |
0 |
19 |
n |
n |
|
4 |
22 |
1 |
0 |
0 |
0 |
22 |
n |
n |
|
5 |
23 |
0 |
0 |
0 |
0 |
23 |
n |
n |
8 |
36 |
16 |
0 |
0 |
0 |
0 |
16 |
n |
n |
0.25% |
37 |
18 |
0 |
0 |
0 |
0 |
17 |
n |
n |
test |
38 |
23 |
0 |
0 |
0 |
0 |
23 |
n |
n |
substance |
39 |
25 |
0 |
0 |
0 |
0 |
25 |
n |
n |
|
40 |
22 |
0 |
0 |
0 |
0 |
22 |
n |
n |
9 |
41 |
17 |
0 |
0 |
0 |
0 |
16 |
++ |
n |
1.0% test |
42 |
18 |
0 |
0 |
0 |
0 |
18 |
n |
n |
substance |
43 |
21 |
0 |
0 |
0 |
0 |
21 |
n |
n |
|
44 |
20 |
0 |
0 |
0 |
0 |
19 |
n |
n |
|
45 |
19 |
0 |
0 |
0 |
0 |
19 |
n |
n |
10 |
46 |
18 |
0 |
0 |
0 |
0 |
18 |
n |
n |
2.5% test |
47 |
20 |
0 |
0 |
0 |
0 |
19 |
n |
n |
substance |
48 |
16 |
0 |
0 |
0 |
0 |
15 |
n |
n |
|
49 |
19 |
0 |
0 |
0 |
0 |
18 |
n |
n |
|
50 |
22 |
0 |
0 |
0 |
0 |
22 |
n |
++ |
Legends: BW =Bodyweight, Relative size nodes(-: reduced,+: enlarged, n: considered to be normal)
• Acetone/Olive oil {4:1 v/v) (NOTOX Project401028)
Note 1: Body weights of animals 36 and 48 were below the weight range of 21±4 grams.
Table 4: Radioactivity measurements {individual animals)
group |
animal |
treatment |
Induction |
DPM / animal |
1 |
1 |
vehicle control |
Acetone/Olive oil (4:1} |
86 |
|
2 |
|
(NOTOX Project 398058) |
66 |
|
3 |
|
|
284 |
|
4 |
|
|
103 |
|
5 |
|
|
216 |
5 |
21 |
experimental |
5% test substance |
2003 |
|
22 |
|
|
3407 |
|
23 |
|
|
3499 |
|
24 |
|
|
1756 |
|
25 |
|
|
3257 |
6 |
26 |
experimental |
25% test substance |
1800 |
|
27 |
|
|
2432 |
|
28 |
|
|
3227 |
|
29 |
|
|
2833 |
|
30 |
|
|
2319 |
7 |
31 |
experimental |
50% test substance |
692 |
|
32 |
|
|
1681 |
|
33 |
|
|
728 |
|
34 |
|
|
169 |
|
35 |
|
|
1337 |
Table 5: Radioactivity measurements (individual animals) (cont'd)
group |
animal |
treatment |
Induction |
DPM / animal |
1 |
1 |
vehicle control |
Acetone/Olive oil (4:1) |
219 |
|
2 |
|
(NOTOX Project 401028) |
280 |
|
3 |
|
|
243 |
|
4 |
|
|
464 |
|
5 |
|
|
105 |
8 |
36 |
experimental |
0.25% test substance |
312 |
|
37 |
|
|
251 |
|
38 |
|
|
197 |
|
39 |
|
|
428 |
|
40 |
|
|
625 |
9 |
41 |
experimental |
1% test substance |
392 |
|
42 |
|
|
611 |
|
43 |
|
|
708 |
|
44 |
|
|
519 |
|
45 |
|
|
1050 |
10 |
46 |
experimental |
2.5% test substance |
820 |
|
47 |
|
|
1101 |
|
48 |
|
|
38# |
|
49 |
|
|
677 |
|
50 |
|
|
383 |
#.Value rejected. Very low and outside the range.
Table 6: Calculation of Stimulation Index (SI)
group |
treatment |
induction |
mean |
Sl±SD |
|
|
|
DPM ±SD |
|
8** |
experimental |
0.25% test substance |
363 ± 170 |
1.4 ± 0.7 |
9** |
experimental |
1% test substance |
656 ± 249 |
2.5 ± 0.6 |
10** |
experimental |
2.5% test substance |
745 ± 299 |
2.8 ± 0.6 |
5* |
experimental |
5% test substance |
2784 ± 835 |
18.4 ± 0.7 |
6* |
experimental |
25% test substance |
2522 ± 540 |
16.7 ± 0.7 |
7* |
experimental |
50% test substance |
921±593 |
6.1 ± 0.9 |
1** |
vehicle control |
Acetone/Olive oil (4:1 v/v) |
262 ± 130 |
1.0 |
1* |
vehicle control |
Acetone/Olive oil (4:1 v/v) |
151±94 |
1.0 |
•. Asterisk indicates the concurrent control used to calculate the SI.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The SI values calculated for the substance concentrations 0.25, 1, 2.5, 5, 25 and 50% were 1.4, 2.5,2.8,18.4,16.7 and 6.1 respectively.
These data showed a dose-response and an EC3 value of 3.4% was calculated.
Based on these results and according to the recommendations made in the test guidelines (OECD No.429, EC B.42 and EPA OPPTS 870.2600), naphthalene-1,5-diol should be regarded as a skin sensitiser.
Based on these results and according to the:
- OECD Harmonized Integrated Hazard Classification System for Human Health and Enviranmental Effects of Chemical Substances (OECD, 1998), naphthalene-1,5-diol should be classified as contact sensitiser.
- EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), naphthalene-1,5-diol should be labelled as: may cause sensitisation by skin contact (R 43). - Executive summary:
Assessment for Contact Hypersensitivity to naphthalene-1,5-diol in the Mouse (Local Lymph Node Assay).
The study was carried out based on the guidelines described in: OECD, Section 4, Health Effects, No.429 (2002), Paris Cedex; EC, Council Directive 67/548/EEC, Annex IV C, B.42 (Draft) (2001); Environmental Protection Agency (EPA): Health Effects Test Guidelines OPPTS 870.2600. "Skin Sensitisation" 2003.
Test substance concentrations selected for the main study were based on the results of a preliminary study.
In the main study, three groups of five experimental animals were epidermally exposed to a 5%, 25% and 50% concentration respectively on three consecutive days. Five vehicle control animals were similarly treated, but with vehicle alone (Acetone/Olive oil (4:1 v/v)(NOTOX Project 398058).
Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) Iymph nodes were excised.
After precipitating the DNA of the Iymph node cells, radioactivity measurements were done. Based on the results, additional groups were treated at 0.25, 1 and 2.5%. Five vehicle control animals were similarly treated, but with vehicle atone (Acetone/Olive oil (4:1 v/v)(NOTOX Project 401028).
The sizes of the majority of nodes were considered to be normal, except for a few nodes among the experimental animals. No other macroscopic abnormalities of the nodes were noted.
Mean DPM/animal values for the experimental groups treated with test substance concentrations 5, 25 and 50% were 2784, 2522 and 921 respectively. The mean DPM/animal value for the vehicle control group was 151.
In order to clarify the dose response relationship, additional groups of animals were treated with test substance concentrations 0.25, 1 and 2.5% were 363,656 and 745 respectively. The mean DPM/animal value for the vehicle control group was 262.
The SI values calculated for the substance concentrations 0.25, 1, 2.5, 5, 25 and 50% were 1.4, 2.5,2.8,18.4,16.7 and 6.1 respectively.
These data showed a dose-response and an EC3 value of 3.4% was calculated.
Based on these results and according to the recommendations made in the test guidelines (OECD No.429, EC B.42 and EPA OPPTS 870.2600), naphthalene-1,5-diol should be regarded as skinsensitiser.
Based on these results and according to the:
- OECD Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998), naphthalene-1,5-diol should be classified as contact sensitiser.
- EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), naphthalene-1,5-diol should be labelled as:
may cause sensitisation by skin contact (R 43).
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